(b)(4) |
Freedom of Information Act Exemption 4, which protects from disclosure ôtrade secrets and commercial |
|
348 |
FDA form for sponsored travel |
|
1932 |
FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report--mandatory |
|
1932a |
FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report--voluntary |
|
21 CFR Part 314 Subpart H |
Subpart of Part 314 pertaining to accelerated approval of drugs |
|
2301 |
FDA form for transmittal of periodic reports and promotional material for new animal drugs |
|
3500 |
FDA form for voluntary reporting of adverse events |
|
3500A |
FDA form for mandatory reporting of adverse events |
|
356V |
FDA form for new animal drug appication |
|
3R |
Recruitment, Relocation bonuses, and Retention allowances |
|
3RS |
Recruitment and Relocation Bonuses and Retention Allowances |
|
406B |
Section of the FDA Modernization Act dealing with getting feedback from our stakeholders |
|
482 |
FDA form for notice of inspection |
|
483 |
FDA form used as a written notice of deficiencies found in inspections |
|
510(k) |
Food, Drug, and Cosmetic Act Section 501(k), Pre-Market Notification |
|
A-V |
ArterioVenous |
|
A-VO2 |
arteriovenous oxygen |
|
A/L |
Annual Leave |
|
A2LA |
American Association for Laboratory Accreditation |
|
AAALAC |
Association for the Assessment and Accreditation of Laboratory Animal Care International |
|
AAAP |
American Association of Avian Pathologists |
|
AAAS |
American Association for the Advancement of Science |
|
AABB |
American Association of Blood Banks |
|
AABP |
American Association of Bovine Practitioners |
|
AACR |
American Association for Cancer Research |
|
AADA |
Abbreviated Antibiotic Drug Application |
|
AAEP |
American Association of Equine Practitioners |
|
AAFCO |
Association of American Feed Control Officials |
|
AAFP |
American Academy of Family Physicians |
|
AAHA |
American Animal Hospital Association |
|
AAI |
American Association of Immunologists |
|
AALAS |
American Association for Laboratory Animal Science |
|
AANN |
American Association of Neurosciences Nurses |
|
AANS |
American Association of Neurological Surgeons |
|
AAO |
American Academy of Ophthalmology |
|
AAP |
American Academy of Pediatrics |
|
AAPHP |
American Association of Public Health Physicians |
|
aapm |
American Association of Physicists in Medicine's |
|
AAR |
After Action Review |
|
AARP |
American Association of Retired Persons |
|
AASA |
Aging and Adult Services Administration |
|
AASP |
American Association of Swine Practitioners |
|
AASRP |
American Association of Small Ruminant Practitioners |
|
AATB |
American Association of Tissue Banks |
|
AAVLD |
American Association of Veterinary Laboratory Diagnosticians |
|
AAVMC |
Association of American Veterinary Medical Colleges |
|
AB |
Analysis Branch |
|
AB (CDRH) |
Analysis Branch (CDRH) |
|
ABC |
American Blood Commission |
|
ABC |
America's Blood Centers |
|
ABCS |
Active Bacterial Core Surveillance |
|
ABE |
Adverse Biologic Experience |
|
ABI |
Automated Broker Interface |
|
Abifarma |
Brazilian Association of the Pharmaceutical Industry |
|
ABLES |
Adult Blood Level Epidemiology & Surveillance |
|
ABM |
Application Briefing Meeting |
|
ABN |
Advance Beneficiary Notice |
|
ABPI |
Association of the British Pharmaceutical Industry |
|
ABRA |
American Blood Resource Association |
|
AC |
Advisory Committee |
|
ACB |
Accreditation and Certification Branch |
|
ACB (CDRH) |
Accreditation and Certification Branch (CDRH) |
|
ACBSA |
Advisory Committee on Blood Safety and Availability |
|
ACC |
RCHSA (Radiation Control for Health and Safety Act) ACCession number |
|
ACCME |
Accreditation Council for Continuing Medical Education |
|
ACCP |
American College of Clinical Pharmacology |
|
ACE |
Automated Commercial Environment (US Customs) |
|
ACE |
Adverse Clinical Event |
|
ACEC |
Autism Centers of Excellence Program (NIH) |
|
ACEP |
American College of Emergency Physicians |
|
ACF |
Administration for Children and Families |
|
ACG |
American College of Gastroenterology |
|
ACGME |
Accreditation Council for Graduate Medical Education |
|
ACIL |
A national trade asociation representing independent, commerical scientific, and engineering firms (formerly the American Council of Independent Laboratories) |
|
ACIP |
Advisory Committee on Immunization Practices |
|
ACLA |
American Clinical Laboratory Association |
|
ACLAD |
American Committee on Laboratory Animal Diseases |
|
ACLAM |
American College of Laboratory Animal Medicine |
|
ACMP |
American College of Medical Physics |
|
ACOL |
Acceptable Carry-Over Limit |
|
ACP |
Advance Care Planning |
|
ACPE |
Accreditation Council for Pharmacy Education |
|
ACPM |
American College of Preventive Medicine |
|
ACR |
American College of Radiology |
|
ACRA |
Associate Commissioner for Regulatory Affairs (Food & Drug Administration) |
|
ACRA (ORA) |
Associate Commissioner for Regulatory Affairs (ORA) |
|
ACRPI |
Association of Clinical Research for the Pharmaceutical Industry |
|
ACS |
Automated Commercial System |
|
ACS (CBER) |
Analytical Chemistry Staff (Center for Biologics Evaluation and Research) |
|
ACS (CDER) |
Advisors and Consultants Staff (Center for Drug Evaluation and Research) |
|
ACSM |
American College of Sports Medicine's |
|
ACT |
Applied Clinical Trials |
|
ACT |
AIDS Clinical Trials |
|
ACTB |
Analytical Chemical Techniques Branch |
|
ACTB (NCTR) |
Analytical Chemical Techniques Branch (NCTR) |
|
ACTH |
Adrenocorticotropic Hormone |
|
ACTIS |
AIDS Clinical Trials Information Service |
|
ACUS |
Administrative Conference of the United States |
|
ACWA |
Administrative Careers With America |
|
AD |
Action Due |
|
AD LIB |
As Much As Needed |
|
ADA |
American Dental Association |
|
ADA |
Americans With Disabilities Act Of 1990 (Text Of ADA Legislation) |
|
ADAA |
Animal Drug Availability Act of 1996 |
|
ADAM |
Analysis Dataset Model |
|
ADAM7 |
Analysis Data Model |
|
ADAMHA |
Alcohol, Drug Abuse, and Mental Health Administration (now SAMHSA) |
|
ADAP |
AIDS Drug Assistance Program |
|
ADCOM |
ADvisory COMmittee |
|
ADE |
Adverse Drug Event |
|
ADE/ADER |
Adverse Drug Experience/Adverse Drug Experience Report |
|
ADEC |
Australian Drug Evaluation Committee |
|
AdEERS |
Adverse Event Expedited Reporting System |
|
ADER |
Adverse Drug Experience Report |
|
ADH |
Antidiuretic Hormone |
|
ADI |
Acceptable Daily Intake (National Academy of Science) |
|
ADMC |
Advance Determination of Medicare Coverage |
|
ADME |
absorption, distribution, metabolism, and excretion |
|
ADMIA |
Associate Director for Medical and International Affairs |
|
ADMIA (CBER) |
Associate Director for Medical and International Affairs (CBER) |
|
ADMS |
Alcohol, Drug Abuse and Mental Health Services |
|
ADP |
Automated Data Processing |
|
ADP |
Associate Director for Policy |
|
ADP |
Alternative Disposition Plan |
|
ADP (CBER) |
Associate Director for Policy (CBER) |
|
ADR |
Adverse Drug Reaction |
|
ADR |
Associate Director for Research |
|
AdR |
Adverse Drug Report |
|
ADR (CBER) |
Associate Director for Research (CBER) |
|
ADRA |
Associate Director of Regulatory Affairs |
|
ADRA |
Administrative Dispute Resolution Act |
|
ADRAC |
Adverse Drug Reactions Advisory Committee |
|
ADRM |
Associate Director for Review Management |
|
ADRM (CBER) |
Associate Director for Review Management (CBER) |
|
ADRP |
Association of Donor Recruitment Professionals |
|
ADRS |
Adverse Drug Reporting System |
|
ADSA |
Aging and Disability Services Administration |
|
ADUFA |
Animal Drug User Fee Act of 2003 |
|
AdvaMed |
Advanced Medical Technology Association |
|
ADWOH |
Average Day's Work On Hand |
|
AE |
Approvable, but not yet approved |
|
AE |
Adverse Event |
|
AE(s) |
adverse event(s) |
|
AEA |
Actual Expense Allowance |
|
AED |
anti-epileptic drug |
|
AER |
Adverse Event Reporting |
|
AERS |
Adverse Event Reporting System (Food & Drug Administration) |
|
AF |
Atrial Fibrillation |
|
AF |
Administrative File |
|
AFAB |
Absorbable Fibrin Adhesive Bandage |
|
AFC |
Adult Foster Care |
|
AFGE |
American Federation of Government Employees |
|
AFIA |
American Feed Industry Association |
|
AFIP |
Armed Forces Institute of Pathology (DoD) |
|
AFP |
Alpha Fetoprotein |
|
AGA |
Association of Government Accounts |
|
AGD |
action goal date |
|
AGRICOLA |
AGRICultural On-Line Access |
|
AHA |
American Hospital Association |
|
AHCPR |
Agency for Health Care Policy and Research |
|
AHF |
Antihemophilic Factor |
|
AHFS |
American Hospital Formulary Service |
|
AHI |
Animal Health Institute |
|
AHIC |
American Health Information Community |
|
AHU |
Air Handling Unit |
|
AI |
Additional Information (Letter) |
|
AICRC |
Association of Independent Clinical Research Contractors |
|
AID |
Agency for International Development (U.S.) |
|
AIIS |
Analogous Industrial Injuries Scheme |
|
AIM |
Active Ingredient Manufacturer |
|
AIMBE |
American Institute For Medical and Biological Engineering |
|
AIMDD |
Active Implantable Medical Device Directive |
|
AIMS |
Agency Information Management System |
|
AIN |
food additive identification number (ORA AofC code) |
|
AIP |
Application Integrity Policy |
|
AIP |
APHIS (Animal and Plant Health Inspection Service) Integrated Planning |
|
AIRIO |
Agency Intramural Research Integrity Officer |
|
AIS |
Automated Information System |
|
AIS |
Abbreviated Inspection System |
|
AL |
Annual Leave |
|
AL |
Approvable Letter |
|
ALARA |
As Low As Reasonably Achievable |
|
ALFB |
Access Litigation and FOI (Freedom Of Information) Branch |
|
ALFB (CBER) |
Acess Litigation and FOI Branch (CBER) |
|
ALJ |
Administrative Law Judge |
|
ALJ (OC) |
Office of the Administrative Law Judge (OC) |
|
ALL |
Adult Acute Lymphocytic Leukemia |
|
ALL |
Acute Lymphocytic Leukemia |
|
ALT |
Alanine Aminotransferase |
|
AMA |
Agricultural Marketing Act of 1946 |
|
AMA |
American Medical Association |
|
AMA-DE |
American Medical Association Drug Evaluation |
|
AMB |
Adminstrative Management Branch |
|
AMB (CDRH) |
Adminstrative Management Branch (CDRH) |
|
AMDUCA |
Animal Medicinal Drug Use Clarification Act of 1994 |
|
AME |
Absorption Metabolism Excretion |
|
AMF |
Administrative Management of Files |
|
AmfAR |
American Foundation for AIDS Research |
|
AMG |
ArzeneiMittelGesetz (West Germany drug law) |
|
AMI |
American Meat Institute |
|
AML |
Acute Myelogenous Leukemia |
|
AMP |
Average Manufacturer Price |
|
AMPI |
Associated Milk Producers Inc. |
|
AMS |
Agricultural Marketing Service |
|
AMS |
Aseptic Meningitis Syndrome |
|
AMT |
Asset Management Team |
|
AMT (OC) |
Asset Management Team (OC) |
|
ANA |
Administration for Native Americans |
|
ANA |
Abbreviated New Animal drug number |
|
ANA |
Antinuclear Antibody |
|
ANADA |
Abbreviated New Animal Drug Application |
|
ANCOVA |
Analysis of Covariance |
|
AND |
Abbreviated New Drug application number |
|
ANDA |
Abbreviated New Drug Application (for a generic drug) |
|
ANOC |
Annual Notice of Changes |
|
ANOVA |
Analysis of Variance (statistics) |
|
ANPR |
Advance Notice of Proposed Rulemaking |
|
ANPRM |
Advance Notice of Proposed Rule Making |
|
ANRC |
American National Red Cross |
|
ANSI |
American National Standards Institute, Inc. |
|
ANZFA |
Australia New Zealand Food Authority (now Food Standards Australia New Zealand) |
|
AO |
Administrative Officer |
|
AoA |
Administration on Aging |
|
AOAC |
Association of Official Analytical Chemists |
|
AOB |
Accounting Operations Branch |
|
AOB (OC) |
Accounting Operations Branch (OC) |
|
AODM |
Adult-Onset Diabetes Mellitus |
|
AofC |
Affirmation of Compliance |
|
AOPC |
Agency/Organization Program Coordinator |
|
APA |
Administrative Procedures Act |
|
APAC |
Allergenic Products Advisory Committee |
|
APAP |
N-Acetyl-Para-Amino-Phenol |
|
APBI |
Association of the British Pharmaceutical Industry |
|
APEC |
Asia-Pacific Economic Cooperation Council |
|
APhA |
American Pharmaceutical Association |
|
APHA |
American Public Health Association |
|
APHIS |
U.S. Department of Agriculture's Animal and Plant Health Inspection Service |
|
APHL |
Association of Public Health Laboratories |
|
API |
Active Pharmaceutical Ingredient |
|
APIC |
Active Pharmaceutical Ingredients Committee (of CEFIC) |
|
APIFARMA |
Associação Portuguesa da Indústria FARMAcêutica (Association of the Portuguese Pharmaceutical Industries) |
|
APLB (CBER) |
Advertising and Promotional Labeling Branch (Center for Biologics Evaluation and Research) |
|
APR |
Annual Product Review |
|
APSB |
Accounting Policy and Systems Branch |
|
APSB (OC) |
Accounting Policy and Systems Branch (OC) |
|
APTF |
Application Policy Task Force |
|
AQL |
Acceptable Quality Level |
|
AR |
approvable letter |
|
ARAB (OC) |
Accounting Reports and Analysis Branch (OC) |
|
ARC |
American Red Cross |
|
ARCH |
Administrative Resources Core Hub |
|
ARCRT |
American Registry of Clinical Radiography Technologists |
|
ARDB |
Anesthesiology and Respiratory Devices Branch |
|
ARDB (CDRH) |
Anesthesiology and Respiratory Devices Branch (CDRH) |
|
ARDS |
Acute Respiratory Distress Syndrome |
|
ARENA |
Applied Research Ethics National Association |
|
ARF |
Acute Renal Failure |
|
ARIES |
Administrative Resources Information Exchange System |
|
ARL |
Arkansas Regional Laboratory |
|
ARL (ORA) |
Arkansas Regional Laboratory (ORA) |
|
ARNet |
Acquisition Reform Network |
|
ARPA |
Advanced Research Projects Agency (made early internet) |
|
ARRT |
American Registry of Radiologic Technologists |
|
ARS |
United States Department of Agriculture's Agricultural Research Service |
|
ART |
Assisted Reproductive Therapy |
|
ARTCA |
Antimicrobial Regulations Technical Correction Act of 1998 |
|
AS |
Administrative Staff |
|
AS |
Aortic Stenosis |
|
AS (CVM) |
Administrative Staff (CVM) |
|
ASA |
Aminosalicylic Acid |
|
ASA |
American Statistical Association |
|
ASAP |
Administrative Systems Automation Project (Food & Drug Administration) |
|
ASAP |
As Soon As Possible (pronounced AY-sap) |
|
ASAS |
American Society of Animal Science |
|
ASB |
Administrative Services Branch |
|
ASB (OC) |
Accounting Services Branch (OC) |
|
ASBPO |
Armed Services Blood Program Office |
|
ASC |
Advertising Standards Council |
|
asco |
American Society of Clinical Oncology's |
|
ASCP |
American Society for Clinical Pathology |
|
ASCPT |
American Society for Clinical Pharmacology and Therapeutics |
|
ASD |
Atrial Septal Defect |
|
ASD (HD) |
Assistant Secretary of Defense for Homeland Defense |
|
ASD(HD) |
Assistant Secretary of Defense for Homeland Defense |
|
ASGE |
American Society for Gastrointestinal Endoscopy |
|
ASHD |
AtheroSclerotic Heart Disease |
|
ASHRAE |
American Society of Heating, Refrigeration & Air Conditioning Engineers |
|
ASIA |
American Sheep Industry Association |
|
ASIC |
Application Specific Integrated Circuit |
|
ASICs |
Application Specific Integrated Circuits |
|
ASLAP |
American Society of Laboratory Animal Practitioners |
|
ASM |
American Society for Microbiology |
|
ASME |
American Society of Mechanical Engineers |
|
ASPE |
Assistant Secretary for Planning and Evaluation |
|
ASPER |
Assistant Secretary for Personnel |
|
ASR |
Analyte Specific Reagent |
|
ASRM |
American Society for Reproductive Medicine |
|
AST |
Aspartate Aminotransferase |
|
ASTHO |
Association of State and Territorial Health Officials |
|
ASTM |
American Society for Testing and Materials (Philadelphia, Pennsylvania) |
|
AT |
Acquisitions Team |
|
AT |
antithrombin III |
|
AT (OC) |
Acquisitions Team (OC) |
|
ATC |
Anatomical Therapeutic Chemical |
|
ATM |
Automatic Teller Machine |
|
ato |
Authorization to Operate |
|
ATPA |
American Technology Pre-eminence Act of 1991 |
|
ATPM |
Association of Teachers and Preventive Medicine |
|
ATS |
Applied Technologies Staff |
|
ATS (CDER) |
Applied Technologies Staff (CDER) |
|
ATSDR |
Agency for Toxic Substance and Disease Registry |
|
AUA |
Agency for Healthcare Research and Quality |
|
AUC |
Area under the Curve (statistics) |
|
AUSA |
Assistant United States Attorney |
|
AV |
Atrio-Ventricular (cardiac) |
|
AVA |
American Veal Association |
|
AVDA |
American Veterinary Distributors Association |
|
AVEG |
AIDS Vaccine Evaluation Group |
|
AVMA |
American Veterinary Medical Association |
|
awc |
Adequate and well-controlled |
|
AWP |
Average Wholesale Price |
|
AWS |
Alternate Work Schedule |
|
B&F |
Budget and Finance |
|
B&F (CVM) |
Budget and Finance Team (CVM) |
|
BA/BE |
Bio-Availability/Bio-Equivalence |
|
BAC |
Billing Agency Code |
|
BaCON |
Bacterial CONtamination |
|
BACPAC |
Bulk ACtivities Post-Approval Changes |
|
BAER |
Brief Adverse Event Report |
|
BAH |
Booz-Allen & Hamilton |
|
BAM |
Bacteriological Analytical Manual |
|
BARC |
Beltsville Area Agricultural Research Service |
|
BARDA |
Biomedical Advanced Research and Development Authority |
|
BARQA |
British Association of Research Quality Assurance |
|
BARS (CDER) |
Business Analysis and Reporting Staff (CDER) |
|
BASIS |
Blood Availability and Safety Inventory System |
|
BATF |
Bureau of Alcohol, Tobacco, & Firearms |
|
BB IND |
Biological-Based Investigational New Drug |
|
BBB |
Bundle Branch Block |
|
BBR |
Bureau of Biologics and Radiopharmaceuticals |
|
BBS |
Bulletin Board System |
|
BC/BS |
Blue Cross and Blue Shield |
|
BCA |
Blood Center of America |
|
BCAA |
branched-chain amino acids |
|
BCB |
Bioanalytical Chemistry Branch |
|
BCB (CFSAN) |
Bioanalytical Chemistry Branch (CFSAN) |
|
BCE |
Beneficial Clinical Event |
|
BCP |
Bureau of Consumer Protection |
|
BCPT |
Breast Cancer Prevention Trial |
|
BDB |
Biologic Devices Branch (CBER) |
|
BDB (CDRH) |
Bacteriology Devices Branch (CDRH) |
|
BDLS |
Blood Donor Locator Service |
|
BDPA |
Bureau of Drug Policy and Administration (China) |
|
BDR |
Budget Data Request |
|
BDS |
Bureau of Drug Surveillance (Canada) |
|
BDSS |
Biologics Decision Support System |
|
BEA |
Bureau of Economic Analysis |
|
BECON |
Bioengineering Consortium |
|
BENS |
Business Executives For National Security |
|
Beq |
bioequivalence |
|
BER |
Blood Establishment Registration and Product Listing |
|
BEST |
Biomonitoring of Environmental Status and Trends (Biological Resources Division, USGS) |
|
BFAC |
Biologics Field Advisory Committee (CBER) |
|
BFAD |
Bureau of Food & Drug Administration |
|
BFArM |
Bundesinstitut Fur Arzneimittel und Medizinprodukte (German Ministry of Health) |
|
BGA |
BundesGesundheitsAmt (German Federal Health Office) |
|
BGH |
Bovine Growth Hormone |
|
BGMA |
British Generic Manufacturers Association |
|
BHPR |
Bureau of Health Professions |
|
BI |
Boehringer Ingelheim |
|
BIA |
Bureau of Indian Affairs (U.S.) |
|
BID |
Bis In Die (Twice Daily) |
|
BIG |
Blacks In Government |
|
BIMO |
bioresearch monitoring |
|
BIMS |
Biologic IND (Investigational New Drug) Management System |
|
BIND |
Biological Investigational New Drug |
|
BIO |
Biotechnology Industry Organization |
|
BIOB (CFSAN) |
Biostatistics Branch (CFSAN) |
|
BIP |
Balancing Incentive Program |
|
BIRA |
British Institute of Regulatory Affairs |
|
BIRAMS |
Biologics Investigational and Related Applications Management System |
|
BISTI |
Biomedical Information Science and Technology Initiative |
|
BISTIC |
Biomedical Information Science and Technology Initiative Consortium |
|
bivas |
Body Image Visual Analog Scale |
|
BLA |
Biologics License Application (Food & Drug Administration) |
|
BLM |
Bureau of Land Management of United States Department of the Interior |
|
BLS |
Biologics License Supplement |
|
BLST |
Building and Laboratory Services Team |
|
BLST (CFSAN) |
Building and Laboratory Services Team (CFSAN) |
|
BLT |
Blood Logging and Tracking System |
|
BMB |
Bioanalytical Methods Branch |
|
BMB (CFSAN) |
Bioanalytical Methods Branch (CFSAN) |
|
BMBL |
Biosafety in Microbiological and Biomedical Laboratories |
|
BMI |
Body Mass Index |
|
BMIS |
Bioresearch Monitoring Information System |
|
BMR |
Basal Metabolic Rate |
|
BMS |
Broadcast Media Staff |
|
BMS (OC) |
Broadcast Media Staff (OC) |
|
BNA |
Bureau of National Affairs, Inc. |
|
BNF |
biotechnology notification file |
|
BOCB |
Biological and Organic Chemistry Branch |
|
BOCB (CFSAN) |
Biological and Organic Chemistry Branch (CFSAN) |
|
BOCF |
Baseline Observation Carried Forward |
|
BOP |
Boards Of Pharmacy |
|
BOS (CBER) |
Building Operations Staff (CBER) |
|
BOS-DO |
BOSton, Massachusetts, District Office |
|
BOS-DO (ORA) |
Boston (Massachusetts) District Office (ORA) |
|
BP |
British Pharmacopoeia |
|
BP |
Blood Pressure |
|
BPA |
Blanket Purchase Agreement |
|
BPA |
Bureau of Pharmaceutical Assessment |
|
BPAC |
Blood Products Advisory Committee |
|
BPB |
Blood and Plasma Branch |
|
BPB (CBER) |
Blood and Plasma Branch (CBER) |
|
BPC |
Bulk Pharmaceutical Chemical |
|
BPC |
Bureau of Policy and Coordination |
|
BPCA |
Best Pharmaceuticals for Children Act of 2002 |
|
BPCI Act |
Biologics Price Competition and Innovation Act of 2009 |
|
BPD |
Biological Product Deviation |
|
BPD |
Bronchopulmonary Dysplasia |
|
BPE |
Bulk Pharmaceutical Excipients |
|
BPHC |
Bureau of Primary Health Care |
|
BPL |
Biologic Product License Number |
|
BPM |
Beats Per Minute |
|
BPR |
Business Process Re-engineering |
|
BPSRG |
Biomedical and Pharmaceutical Sciences Research Group |
|
BPWG |
Business Process Working Group |
|
BRAIN |
Brain Research through Advancing Innovative Neurotechnologies |
|
BrAPP |
British Association of Pharmaceutical Physicians |
|
BRB |
Biometric Research Branch |
|
BRCC |
Biologics Research Coordinating Committee |
|
BRFSS |
Behavioral Risk Factor Surveillance System |
|
BRMAC |
Biological Response Modifiers Advisory Committee |
|
BRMD |
Bureau of Radiation and Medical Devices |
|
BRMS |
Biologics Regulatory Management System |
|
BSA |
Broad-Spectrum Antibiotic |
|
BSA |
Body Surface Area |
|
BSB |
Biotechnology Studies Branch (Chicago, Illinois) |
|
BSB (CFSAN) |
Biotechnology Studies Branch (Chicago, Illinois) (CFSAN) |
|
BSC |
Biological Safety Cabinet |
|
BSC |
Business Service Center |
|
BSC |
Blood Safety Committee |
|
BSD |
Blood Service Directive |
|
BSE |
bovine spongiform encephalopathy (mad cow disease) |
|
BSI |
British Standards Institute |
|
BSL |
Biosafety Level |
|
BST |
Bovine Somatotropin |
|
BSTS |
Bundled Supplement Tracking System |
|
BT |
Bioterrorism |
|
BT |
Bacillus thuringiensis Berliner |
|
BT Act |
Bioterrorism Act (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) |
|
BTA |
BioTerroism Act of 2002 |
|
BTCB |
Blood and Tissue Compliance Branch |
|
BTCB (CBER) |
Blood and Tissue Compliance Branch (CBER) |
|
BTR |
Blood and Tissue Registration System |
|
BUF-DO |
BUFfalo, New York, District Office |
|
BUF-DO (ORA) |
Buffalo (New York) District Office (ORA) |
|
BUN |
Blood Urea Nitrogen |
|
BUS |
BIMS (Biologic IND (Investigational New Drug) Management System) User Support Group |
|
BVB |
Bacterial Vaccine and Allergenic Products Branch |
|
BVC |
British Veterinary Codex |
|
BW |
Body Weight |
|
BWM |
basic workload measurement |
|
BWM |
Biologics Workload Management |
|
BX |
Biopsy |
|
c |
Gl With Correction |
|
c |
Gl With Glasses |
|
c |
with (usually written with a bar on top of the "c") |
|
C & R |
corrections and removals |
|
C & S |
Culture and Sensitivity |
|
C of A |
Certificate of Analysis |
|
C&R |
Corrections and Removals |
|
C&S |
Culture and Sensitivity |
|
C-CDA |
Consolidated - Clinical Document Architecture |
|
C-TPAT |
Customs-Trade Partnership Against Terrorism |
|
C/CC |
Career or Career Conditional |
|
C3I |
communications, command, control, and intelligence |
|
CA |
Competent Authority |
|
CA |
Chemical Abstracts |
|
CA |
Committee Assignment |
|
CAAT |
Center for Alternatives to Animal Testing |
|
CAB |
Conformity Assessment Body |
|
CAB (OC) |
Computer Applications Branch (OC) |
|
CABE |
corrective action(s) being effected |
|
CABG |
Coronary Artery Bypass Graft |
|
caBIG |
Cancer Biomedical Informatics Grid (NIH) |
|
CABP |
Community-Acquired Bacterial Pneumonia |
|
CABS |
Conformity Assessment Bodies |
|
CAC |
Carcinogenicity Assessment Committee |
|
CACBERS |
Committee for the Advancement of CBER Science |
|
CACTIS |
Center ADP/TC Computer Tracking and Inventory System |
|
CAD |
Coronary Artery Disease |
|
CaDSR |
Cancer Data Standards Repository |
|
CAERS |
CFSAN (Center for Food Safety and Applied Nutrition) Adverse Event Reporting System |
|
CAERST (CFSAN) |
CFSAN Adverse Event Reporting System Team |
|
CAFDAS |
Committee for the Advancement of FDA Science |
|
CALA |
computer-assisted license application |
|
cAMP |
Childhood Asthma Management Program |
|
CAN |
Common Accounting Number |
|
CAO |
Change of Appointing Office |
|
CAP |
Color Additive Petition |
|
CAP |
College of American Pathologists |
|
CAP |
Corrective Action Plan |
|
CAP |
Control of Automated Processes |
|
CAPA |
Corrective And Preventive Action |
|
CAPAR |
Corrective Action Preventive Action Report |
|
CAPD |
Continuous Ambulatory Peritoneal Dialysis |
|
CAPLA |
Computer-Assisted Product License Application |
|
CAPLAR |
Computer-Assisted Product License Application Review |
|
CAPRA |
Canadian Association of Professional Regulatory Affairs |
|
CARES |
Cardiac Arrest Registry to Enhance Survival [CDC] |
|
CARS |
Compliance Achievement Reporting System |
|
CARTS |
CFSAN (Center for Food Safety and Applied Nutrtition) Automated Research Tracking System |
|
CAS |
Chemical Abstract Service |
|
CASE |
Computer-Aided Software Engineering |
|
CASPER |
Center Automated System Process Exchange and Reporting |
|
CAST |
Calf Antibiotic and Sulfonamide Test |
|
CATCH |
Child and Adolescent Trial for Cardiovascular Health |
|
CBC |
Complete Blood Count |
|
CBCTN |
Community-Based Clinical Trials Network |
|
CBE |
Changes Being Effected |
|
CBER |
Center for Biologics Evaluation and Research |
|
CBG |
Capillary Blood Gas |
|
CBIAC |
Chemical and Biological Defense Information Analysis Center |
|
CBO |
Congressional Budget Office |
|
CBP |
Customs and Border Protection |
|
CBRA |
California Biomedical Research Association |
|
CBRG |
Cancer Biomarkers Research Group |
|
CBSC |
Cord Blood Stem Cells |
|
CC |
Conference Call |
|
CC |
Coordinating Committee |
|
CC |
Chief Complaint |
|
CC |
Clinical Center |
|
CC |
Commissioned Corps |
|
CC/RVDF |
Codex Committee on Residues of Veterinary Drugs in Foods |
|
CCA |
Clinger-Cohen Act (formerly the Information Technology Management Reform Act) |
|
CCB (CFSAN) |
Color Certification Branch (CFSAN) |
|
CCBC |
Council of Community Blood Centers |
|
CCC |
Chinese ceramicware factory code (ORA AofC code) |
|
CCC |
Commodity Credit Corporation |
|
CCC |
Compliance Coordinating Committee |
|
CCEHRP |
Committee to Coordinate Environmental Health and Related Programs (PHS) |
|
CCFAC |
Codex Committee on Food Additives and Contaminants |
|
CCFICS |
Codex Committee on Food Import and Export Certification and Inspection Systems |
|
CCFL |
Codex Committee on Food Labeling |
|
CCHIT |
Certification Commission for Healthcare Information Technology |
|
CCI |
Corrected Count Increment |
|
CCID |
Coordinating Center for Infectious Diseases |
|
CCOHTA |
Canadian Coordinating Office for Health Technology Assessment |
|
CCOP |
Community Clinical Oncology Program |
|
CCP |
Critical Control Point |
|
CCPR |
Codex Committee on Pesticide Residues |
|
CCR |
Center for Cancer Research |
|
CCRA |
Clinical Contract Research Association |
|
CCRC |
Certified Clinical Research Coordinator |
|
CCST |
Clinical Chemistry Support Team |
|
CCST (CFSAN) |
Clinical Chemistry Support Team (CFSAN) |
|
CCU |
Clean Catch Urine |
|
CCVDF |
Codex Committee on Veterinary Drugs in Foods |
|
CDA |
Clinical Document Architecture |
|
CDASH |
Clinical Data Acquisition Standards Harmonization |
|
CDC |
Centers for Disease Control and Prevention |
|
CDCP |
Centers for Disease Control and Prevention |
|
CDDI |
Collaboration for Drug Development Improvement |
|
CDDTB (CBER) |
Career Development and Directed Training Branch (CBER) |
|
CDER |
Center for Drug Evaluation and Research (Food & Drug Administration) |
|
CDIS |
Component Distribution Information System |
|
CDISC |
Clinical Data Interchange Standards Consortium (formerly a DIA special interest group called the Clinical Data Interchange Standards Committee) |
|
CDISC |
Clinical Data Interchange Standards Committee |
|
CDM |
Clinical Data Management |
|
CDP |
Career Development Plan |
|
CDP |
Candidate Development Program |
|
CDR |
Cognitive Drug Research |
|
CDR |
Central Document Room |
|
CDR |
Clinical Drug Request |
|
CDRH |
Center for Devices and Radiological Health (Food & Drug Administration) |
|
CDRS (CFSAN) |
Case Development and Recall Staff (CFSAN) |
|
CDSA |
Controlled Drugs and Substances Act (Canada) |
|
CDTL |
Cross Discipline Team Leader |
|
CDUS |
Clinical Data Update System (NCI) |
|
CE |
Continuing Education |
|
CE Mark |
CE (Conformite Europeene or European Conformity) marking |
|
CEA |
Council of Economic Advisors |
|
CEARS |
CBER (Center for Biologics Evaluation and Research) Error and Accident Reporting System |
|
CEB (CDER) |
Clinical Evaluation Branch (CBER) |
|
CEB (CFSAN) |
Compliance and Enforcement Branch (CFSAN) |
|
CEDR |
Comprehensive Epidemiologic Data Resource (U.S. Department of Energy) |
|
CEF |
chick embryo fibroblast |
|
CEFIC |
Conseil Européen des Fédérations de l'Industrie Chimique (European Chemical Industry Council |
|
CEMB (CDRH) |
Cardiac Electrophysiology and Monitoring Devices Branch (CDRH) |
|
CEN |
Comite Europeen de Normalisation (European Committee for Standardization) |
|
CENELEC |
Comite Europeen de Normalisation Electrotechnique (European Committee for Electrotechnical Standardization) |
|
CEO |
Chief Executive Officer |
|
CEPPO |
Chemical Emergency Preparedness and Prevention Office (EPA) |
|
CEQ |
Council on Environmental Quality (U.S.) |
|
CERCLIS |
Comprehensive Environmental Response, Compensation and Liability Information System (EPA) |
|
CERG |
CBER Emergency Relocation Group |
|
CERT |
Community Emergency Response Team |
|
CERTS |
Centers for Education and Research on Therapeutics (DHHS) |
|
CES (CFSAN) |
Consumer Education Staff (Center for Food Safety and Applied Nutrition) |
|
CET (CFSAN) |
Clinical Evaluation Team (Center for Food Safety and Applied Nutrition) |
|
CEU |
Continuing Education Units |
|
CF |
Cystic Fibrosis |
|
CFA |
Catfish Farmers of America |
|
CFBR |
Center for Biologics Research |
|
CFC |
Combined Federal Campaign |
|
CFDA |
Catalog of Federal Domestic Assistance |
|
CFG |
Certificate for Foreign Government |
|
CfG |
Center for Functional Genomics |
|
CFIA |
Canadian Food Inspection Agency |
|
CFN |
Central File Number |
|
CFO |
Communication Filing Officer |
|
CFO (OC) |
Chief Financial Officer (OC) |
|
CFOC |
Chief Financial Officers Council |
|
CFOI |
Census of Fatal Occupational Injuries |
|
CFR |
Code of Federal Regulations |
|
CFR |
Contract Financial Requirements |
|
CFSAN |
Center for Food Safety and Applied Nutrition |
|
CFU |
Colony Forming Unit (for Bacteria Counting In Water Disinfection) |
|
CGCS |
computer-generated cover sheet |
|
CGI |
Common Gateway Interface |
|
CGL |
Chronic Granulocytic Leukemia |
|
CGMP |
current Good manufacturing practicess |
|
CGMPR |
Current Good Manufacturing Practices Regulations |
|
CGS (ORA) |
Contract and Grants Staff (ORA) |
|
CGTP |
Current Good Tissue Practice |
|
CH |
Clinical Hold |
|
CHAMPVA |
Civilian Health And Medical Program Of The Department Of Veterans Affairs |
|
CHCB (CFSAN) |
Chemical Contaminants Branch (CFSAN) |
|
CHD |
Coronary Heart Disease |
|
CHF |
Congestive Heart Failure |
|
CHI |
Consolidated Health Initiative |
|
CHID |
Combined Health Information Database (NIH) |
|
CHII |
Consolidated Health Informatics Initiative |
|
CHIP |
Children's Health Insurance Program |
|
CHISSA |
Center for High Integrity Software System Assurance |
|
ChLIA |
chemi-luminescent immunoassay |
|
CHMP |
Committee for Medicinal Products for Human Use |
|
CHO |
Carbohydrate |
|
CHPA |
Consumer Healthcare Products Association |
|
CHSB (CFSAN) |
Chemical Hazards Science Branch (CFSAN) |
|
CI |
Clinical Investigator |
|
CI |
Confidential Informant |
|
CI/KR |
Critical Infrastructure and Key Resources |
|
CIA |
Central Intelligence Agency |
|
CIAC |
Computer Incident Advisory Capability |
|
CIAO |
Critical Infrastructure Assurance Office |
|
CIB |
Clinical Investigator's Brochure |
|
CIB (CFSAN) |
Compliance Information Branch (CFSAN) |
|
CID |
Center for Infectious Diseases |
|
CIN |
Color Index number (ORA AofC code) |
|
CINAHL |
Cumulative Index to Nursing and Allied Health Literature |
|
CIO |
Chief Information Officer |
|
CIOMS |
Council for International Organizations of Medical Sciences |
|
CIP |
Clean-In-Place |
|
CIP |
Critical Infrastructure Protection (US) |
|
CIPP |
Critical Infrastructure Protection Program |
|
CIQI |
Clinical Investigator Qualification Information |
|
CIR |
Cosmetic Ingredient Review |
|
CIRMS |
Council on Ionizing Radiation Measurements and Standards |
|
CIRS |
Center Information Retrieval System |
|
CIS |
Catastrophic Incident Supplement |
|
CIS |
Cancer Information Service |
|
CISET |
Committee on International Science Engineering and Technology |
|
CIT |
Center for Information Technology |
|
CITES |
Convention on International Trade in Endangered Species of Wild Fauna and Flora |
|
CJD |
Creutzfeldt-Jakob Disease |
|
CLA |
conference lodging allowance |
|
CLIA |
Clinical Laboratory Improvement Amendment |
|
CLSI |
Clinical and Laboratory Standards Institute |
|
CLT |
Central Limit Theorem |
|
Cm |
Committee Meeting |
|
Cm |
Chemistry and Manufacturing |
|
Cm |
Case Management |
|
CM |
Configuration Management |
|
CMA |
Chemical Manufacturers Association |
|
CMC |
Chemical Manufacturing Control |
|
CMCCC |
Chemistry and Manufacturing Controls Coordinating Committee |
|
CME |
Continuing Medical Education |
|
CMG |
Cetyl Myristoleate, MSM, Glucosamine |
|
CMGB |
Cae Management and Guidance Branch |
|
CMGB (CDER) |
Cae Management and Guidance Branch (CDER) |
|
CMHS |
Center for Mental Health Services |
|
CMMI |
Center for Medicare and Medicaid Innovation |
|
CMO |
Contract Management Organization |
|
CMP |
Civil Money Penalty |
|
CMP/ HMO |
Comprehensive Medical Plan/Health Maintenance Organization |
|
CMS |
Centers for Medicare and Medicaid Services (formerly Health Care Financing Administration) |
|
CMT |
Cosmetics Toxicology Branch |
|
CMV |
Cytomegalovirus |
|
CN |
Cranial Nerve |
|
CND |
Cardiovascular/Neurological Devices Branch |
|
CND (CDRH) |
Cardiovascular/Neurological Devices Branch (CDRH) |
|
CNPP |
USDA Center for Nutrition Policy and Promotion |
|
CNS |
Central Nervous System |
|
CNS |
Congress of Neurological Surgeons |
|
CO |
Compliance Officer |
|
CO |
Commissioned Officer |
|
CO |
Contract Officer |
|
COA |
Certificate of Analysis |
|
Cob |
close of business (End of duty day) |
|
COB (OC) |
Contract Operations Branch (Office of the Commissioner) |
|
COBRA |
Consolidated Omnibus Budget Reconciliation Act of 1985 |
|
COBTA |
Council On Biologics and Therapeutic Agents |
|
COCB |
Communication and Coordination Branch |
|
COCB (CFSAN) |
Communication and Coordination Branch (CFSAN) |
|
CODB |
Cardiovascular and Ophthalmic Devices Branch |
|
CODB (CDRH) |
Cardiovascular and Ophthalmic Devices Branch (CDRH) |
|
CODEX |
Codex Alimentarius collection of food standards |
|
COE |
Certificate of Exportability |
|
COE |
Center of Excellence |
|
COFEPRIS |
Comisi�n Federal para la Protecci�n contra Riesgos Sanitarios (Federal Commission for the Protection Against Sanitary Risks) (Mexico) |
|
COI |
Conflict Of Interest |
|
COLA |
Cost Of Living Allowance |
|
COLD |
Chronic Obstructive Lung Disease |
|
COMAH |
Control Of Major Accident Hazards Regulation of 1999 |
|
COMSTAT |
COMpliance STATus Information System |
|
CONOPS |
Concept of Operations |
|
CONSER |
Cooperative Online Serials |
|
CONUS |
Continental United States (48 Contiguous States and DC) |
|
COOL |
country-of-origin labeling |
|
COOP |
Continuity of Operations Project |
|
COOP |
Continuity of Operations Procedure |
|
coop |
Continuity of Operations Policy |
|
COOP |
Continuity of Operations Program |
|
COOP |
Continuity of Operations |
|
COP |
Continuation Of Pay |
|
COP |
Coastal Ocean Program |
|
COP |
Clean Out of Place |
|
COPD |
Chronic Obstructive Pulmonary Disease |
|
COPR |
Council of Public Representatives (NIH OD) |
|
COPTRG |
Community Oncology and Prevention Trials Research Group (NCI) |
|
CORE |
Central REpository module |
|
COS |
Certificate of Suitability |
|
COS |
cosmetic registration number (ORA AofC code) |
|
COS (CFSAN) |
Cosmetics Staff (CFSAN) |
|
COSTART |
Coding Symbols for Thesaurus of Adverse Reaction Terms |
|
COTA |
Career Opportunities Training Agreement (HHS) |
|
COTB (CBER) |
Communication Technology Branch (CBER) |
|
COTT |
Committee Of Ten Thousand |
|
CP |
Cerebral Palsy of New Jersey |
|
CP |
Compliance Program |
|
CP |
Chest Pain |
|
CP |
Citizen Petition |
|
CPAC |
Central Pharmaceutical Affairs Council (Japan) |
|
CPAP |
Continuous Positive Airway Pressure |
|
CPB (CFSAN) |
Compliance Programs Branch (CFSAN) |
|
CPC |
Compliance Policy Council |
|
CPCSEA |
Committee for the Purpose of Control and Supervision on Experiments on Animals (India) |
|
CPDF |
Central Personnel Data File (OPM) |
|
CPE |
Continuing Professional Educational |
|
CPFP |
Cancer Prevention Fellowship Program (NCI) |
|
CPG |
Compliance Policy Guide |
|
CPGM |
Compliance Program Guidance Manual |
|
CPI |
Consumer Price Index |
|
CPI |
Critical Path Institute |
|
CPID |
Certified Product Information Document (Canada) |
|
CPK |
Creatinine Phosphokinase |
|
CPMP |
Committee for Proprietary Medicinal Products |
|
CPMS |
Chief, Project Management Staff (CDER) |
|
CPP |
Critical Process Parameter |
|
CPP |
Certificate of Pharmaceutical Product |
|
CPR |
Cardiopulmonary Resuscitation |
|
CPS |
Compendium of Pharmaceuticals and Specialties |
|
CPSA |
Consumer Product Safety Act |
|
CPSC |
Consumer Product Safety Commission |
|
CPT |
Current Procedural Terminology |
|
CR |
COLLECTION REPORT |
|
CRA |
Clinical Research Associate |
|
CRADA |
Cooperative Research and Development Agreement (with National Institutes of Health) |
|
CRB |
Change Review Board |
|
CRB (CBER) |
Clinical Review Branch (CBER) |
|
CRC |
Civil Rights Center (U.S. Department of Labor) |
|
CRC |
Clinical Research Coordinator |
|
CRCL |
Creatinine Clearance |
|
CRCPD |
Conference of Radiation Control Program Directors |
|
CRF |
Case Report Form |
|
CRF |
Chronic Renal Failure |
|
CRIS |
Clinical Research Information System (NIH) |
|
CRIX |
Clinical Research Information Exchange |
|
CRL |
Complete Response Letter |
|
CRM |
corporate records management |
|
CRMT (OC) |
Cosmetics Toxicology Branch (CFSAN) |
|
CRMTS |
CBER (Center for Biologics Evaluation and Research) Regulatory Meetings management Tracking System |
|
CRO |
Clinical Research Organization |
|
CRO |
Contract Research Organization |
|
CRP |
Cold Reactive Protein |
|
CRR |
Consult Review Request |
|
CRS |
Congressional Research Service |
|
CRS |
Contamination Response System |
|
CRTP |
Clinical Research Training Program |
|
CRU |
Center Recall Unit |
|
CRWG |
Hurricane Katrina Comprehensive Review Working Group |
|
CS |
Clinically significant |
|
CS |
Civil Service |
|
CS (CVM) |
Communications Staff (CVM) |
|
CS (OC) |
Communications Staff (OC) |
|
CSA |
Controlled Substances Act |
|
CSA |
Clinical Study Agreement |
|
CSAP |
Center for Substance Abuse Prevention (SAMHSA) |
|
CSAT |
Center for Substance Abuse Treatment (SAMHSA) |
|
CSB |
Chemical Safety and Hazard Investigation Board |
|
CSB (OC) |
Customer Support Branch (Office of the Commissioner) |
|
CSB (ORA) |
Customer Support Branch (Office of Regulatory Affairs) |
|
CSC |
Centre for Surveillance Coordination |
|
CSC |
Cigarette Smoke Concentrate |
|
CSC |
Computational Science Center |
|
CSDD |
Center for the Study of Drug Development (Tufts University) |
|
CSF |
Cerebrospinal Fluid |
|
CSG |
Counterterrorism Security Group |
|
CSI |
Consumer Safety Inspector |
|
CSM |
Committee on Safety of Medicines |
|
CSO |
Consumer Safety Officer |
|
CSPDB |
Circulatory Support and Prosthetic Devices Branch |
|
CSPDB (CDRH) |
Circulatory Support and Prosthetic Devices Branch (CDRH) |
|
CSPI |
Center for Science in the Public Interest |
|
CSR |
Customer Service Representative |
|
CSR |
Customer Service Record |
|
CSR |
Clinical Study Report |
|
CSR |
Center for Scientific Review |
|
CSREES |
Cooperative State Research, Education, and Extension Services |
|
CSS (CDER) |
Controlled Substance Staff (CDER) |
|
CST |
Consumer Safety Technician |
|
CST (CFSAN) |
Consumer Studies Team (CFSAN) |
|
CSTE |
Council of State & Territorial Epidemiologists |
|
CSV |
Comma Separated Values file format |
|
CSV |
Computer System Validation |
|
CT |
Computed Tomography |
|
CT |
Clinical Trial |
|
CTA |
Clinical Trial Application |
|
CTA |
Clinical Trial Agreement |
|
CTAP |
Career Transition Assistance Plan |
|
CTB (CBER) |
Cell Therapies Branch (CBER) |
|
CTC |
Chlortetracycline |
|
CTC |
Common Toxicity Criteria |
|
CTC |
Clinical Trial Certificate (U.K.) |
|
CTCAE |
Common Terminology Criteria for Adverse Events |
|
CTD |
Common Technical Document |
|
CTDB 1 |
Chemistry and Toxicology Devices Branch 1 |
|
CTDB 1 (CDRH) |
Chemistry and Toxicology Devices Branch 1 (CDRH) |
|
CTDB 2 |
Chemistry and Toxicology Devices Branch 2 |
|
CTDB 2 (CDRH) |
Chemistry and Toxicology Devices Branch 2 (CDRH) |
|
CTEB |
Cosmetics TEchnology Branch |
|
CTEB (CFSAN) |
Cosmetics Technology Branch (CFSAN) |
|
CTEP |
Cancer Therapy Evaluation Program |
|
CTFA |
Cosmetic, Toiletry, and Fragrance Association |
|
CTIA |
Cellular Telecommunications and Internet Association's |
|
CTM |
Clinical Trials Materials |
|
CTO |
Clinical Trial Outline |
|
CTOB |
Cosmetics TOxicology Branch |
|
CTP |
Center for Tobacco Products |
|
CTS |
Correspondence Tracking System |
|
CTS |
counseling and testing site |
|
CTTB (CBER) |
Cellular and Tissue Therapy Branch (CBER) |
|
CTTI |
Clinical Trials Transformation Initiative |
|
CTX |
Clinical Trials Exemption |
|
CU |
Consumer's Union |
|
CUE |
Confidential Unit Exclusion |
|
CUF |
Commissione Unica del Farmaco (Italy) |
|
CUVP |
Committee for Veterinary Medicinal Products (EMEA) |
|
CV |
Curriculum Vitae |
|
CV |
Cardiovascular |
|
CVA |
Costovertebral Angle |
|
CVA |
Cerebrovascular Accident |
|
CVD |
Cardiovascular Disease |
|
CVM |
Center for Veterinary Medicine (Food & Drug Administration) |
|
CVMP |
Committee on Veterinary Medical Products |
|
CVP |
Central Venous Pressure |
|
CWD |
Chronic Wasting Disease |
|
CY |
Calendar Year |
|
D & C |
Dilation and Curettage |
|
D0AF (CDRH) |
Division of Planning, Analysis and Finance (CDRH) |
|
DA |
Division of Accounting |
|
DA (OC) |
Division of Accounting (OC) |
|
DAA |
Designated Approving Authority |
|
DAAP (CDER) |
Division of Anesthesia and Analgesia Products (CDER) |
|
DAARP (CDER) |
Division of Anesthesia, Analgesia, and Rheumatology Products (CDER) |
|
DAAS |
Division of Aging and Adult Services |
|
DAC (CFSAN) |
Division of of Analytical Chemistry (CFSAN) |
|
DADS |
Department of Aging and Developmental Services |
|
DADS |
Developers and Distributors System |
|
DADS (CDER) |
Division of Applications Development and Services (CDER) |
|
DAE (OC) |
Division of Applied Engineering (OC) |
|
DAEA II |
Division of Adverse Event Analysis 2 |
|
DAF (CVM) |
Division of Animal Feeds (CVM) |
|
DAFM (CVM) |
Division of Animal and Food Microbiology (CVM) |
|
DAGID (CDRH) |
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (CDRH) |
|
DAIDS |
Division of AIDS (NIAID) |
|
DailyMed |
NLM-based database of information on marketed drugs including FDA-approved labels. |
|
DAIOP (CDER) |
Division of Anti-infective and Ophthalmology Products (CDER) |
|
DAL |
Defect Action Level |
|
DAPR (CDER) |
Division of Applied Pharmacology Research (CDER) |
|
DAR |
Division of Animal Research |
|
DAR (CVM) |
Division of Animal Research (CVM) |
|
DARPA |
Defense Advanced Research Projects Agency (DoD) |
|
DARRTS |
Document Archiving, Reporting, and Regulatory Tracking System |
|
DART |
Developmental And Reproductive Toxicology (database / base de données) |
|
DAS (CFSAN) |
Division of Administrative Services Management (CFSAN) |
|
DAS (NCTR) |
Division of Administrative Services (NCTR) |
|
DAT |
Diet As Tolerated |
|
DATS |
Document Accountability and Tracking System |
|
DAVP (CDER) |
Division of Anti-viral Products (CDER) |
|
DAWN |
(U.S.) Drug Abuse Warning Network |
|
Db |
Double-Blind |
|
DB (CBER) |
Division of Biostatistics (CBER) |
|
DB (CDRH) |
Division of Biology (CDRH) |
|
DB I (CDER) |
Division of Biometrics I (CDER) |
|
DB II (CDER) |
Division of Biometrics II (CDER) |
|
DB III (CDER) |
Division of Biometrics III (CDER) |
|
DB IV (CDER) |
Division of Biometrics IV (CDER) |
|
DB V (CDER) |
Division of Biometrics V (CDER) |
|
DB VI (CDER) |
Division of Biometrics VI (CDER) |
|
DBA |
Doing Business As |
|
DBA (CBER) |
Division of Blood Applications (CBER) |
|
DBC (CFSAN) |
Division of Bioanalytical Chemistry (CFSAN) |
|
DBCP (CBER) |
Division of Blood Collection and Processing (CBER) |
|
DBE (CDER) |
Division of Bioequivalence (CDER) |
|
DBEC (OC) |
Division of Budget Execution and Control (OC) |
|
DBEPA (CBER) |
Division of Blood Establishment and Product Applications (CBER) |
|
DBGNR (CFSAN) |
Division of Biotechnology and GRAS Notice Review (CFSAN) |
|
DBM (CDRH) |
Division of Bioresearch Monitoring (CDRH) |
|
DBMS |
Database Management System |
|
DBOP (CDER) |
Division of Biologic Oncology Products (CDER) |
|
DBPAP (CBER) |
Division of Bacterial, Parasitic and Allergenic Products (CBER) |
|
DBRA |
Division of Biometry and Risk Assessment |
|
DBRA (NCTR) |
Division of Biometry and Risk Assessment (NCTR) |
|
DBS (CDRH) |
Division of Biostatistics (CDRH) |
|
DBT (NCTR) |
Division of Biochemical Toxicology (NCTR) |
|
dc |
Discharge Conduit |
|
dc |
Discharge in Cylindrical |
|
dc |
Discharge Clinic |
|
dc |
Discharge Capacity |
|
dc |
Discharge Curve |
|
dc |
discontinue |
|
DC |
Discharge |
|
DC (CVM) |
Division of Compliance (CVM) |
|
DC (NCTR) |
Division of Chemistry (NCTR) |
|
DC I (CDER) |
Division of Chemistry I (CDER) |
|
DC II (CDER) |
Division of Chemistry II (CDER) |
|
DC III (CDER) |
Division of Chemistry III (CDER) |
|
DCB (CFSAN) |
Domestic Compliance Branch (CFSAN) |
|
DCC |
Document Control Center |
|
DCC (CFSAN) |
Division of Cosmetics and Compliance (CFSAN) |
|
DCC (OC) |
Division of Customer Care (OC) |
|
DCCA (CBER) |
Division of Communication and Consumer Affairs (CBER) |
|
DCCT (CFSAN) |
Division of Color Certification and Technology (CFSAN) |
|
DCD (CDRH) |
Division of Cardiovascular Devices (CDRH) |
|
DCEPT (CBER) |
Division of Clinical Evaluation and Pharmacology/Toxicology (CBER) |
|
DCF |
Data Clarification request Form |
|
DCGM (OC) |
Division of Contracts and Grants Management (OC) |
|
DCGT (CBER) |
Division of Cell and Gene Therapies (CBER) |
|
DCIA |
Debt Collection Act of 1996 |
|
DCIQA (ORA) |
Division of Compliance Information and Quality Assurance (ORA) |
|
DCIS |
Design Control Inspection Strategy |
|
DCLD (CDRH) |
Division of Clinical Laboratory Devices (CDRH) |
|
DCM |
Division of Case Management |
|
DCM (CBER) |
Division of Case Management (CBER) |
|
DCM (CDRH) |
Division of Communications Media (CDRH) |
|
DCMO (ORA) |
Division of Compliance Management and Operations (ORA) |
|
DCMS (CDRH) |
Division of Chemistry and Material Science (CDRH) |
|
DCP (CFSAN) |
Division of Cooperative Programs (CFSAN) |
|
DCP (NCTR) |
Division of Contracts and Procurement (NCTR) |
|
DCP (ORA) |
Division of Compliance Policy (ORA) |
|
DCP 1 (CDER) |
Division of Clinical Pharmacology 1 (CDER) |
|
DCP 2 (CDER) |
Division of Clinical Pharmacology 2 (CDER) |
|
DCP 3 (CDER) |
Division of Clinical Pharmacology 3 (CDER) |
|
DCP 4 (CDER) |
Division of Clinical Pharmacology 4 (CDER) |
|
DCP 5 (CDER) |
Division of Clinical Pharmacology 5 (CDER) |
|
DCPA (CBER) |
Division of Congressional and Public Affairs (Center for Biologics Evaluation and Research) |
|
DCPS |
Defense Civilian Pay System |
|
DCRER (CFSAN) |
Division of Chemistry Research and Environmental Review (CFSAN) |
|
DCRMS (CDER) |
Division of Compliance Risk Management and Surveillance (CDER) |
|
DCRP (CDER) |
Division of Cardiovascular and Renal Products (CDER) |
|
DCSC (OC) |
Division of Construction and Service Contracts (OC) |
|
DCT (CDER) |
Division of Counter-terrorism (CDER) |
|
DCTD (CDRH) |
Division of Chemistry and Toxicology Devices (CDRH) |
|
DCU |
Document Control Unit |
|
DD |
Department of Drugs (Swedish regulatory agency) |
|
DD |
Division Director |
|
DD (CVM) |
District Director (Center for Veterinary Medicine) |
|
DDA |
Division of Drug Analysis |
|
DDB |
Dental Devices Branch |
|
DDB (CDRH) |
Diagnostic Devices Branch (Center for Devices and Radiological Health) |
|
DDDP |
Division of Dermatology and Dental Products |
|
DDDP (CDER) |
Division of Dermatology and Dental Products (CDER) |
|
DDE |
Dymanic Data Exchange |
|
DDES |
Division of Dairy and Egg Safety |
|
DDES (CFSAN) |
Division of Dairy and Egg Safety (CFSAN) |
|
ddI |
Division of Drug Information |
|
DDI (CDER) |
Division of Drug Information (CDER) |
|
DDM |
Division of Dockets Management |
|
DDM (NCTR) |
Deputy Director for Management (National Center for Toxicological Research) |
|
DDM (OC) |
Division of Dockets Management (OC) |
|
DDMAC |
Division of Drug Marketing, Advertising, and Communications |
|
DDMAC (CDER) |
Division of Drug Marketing, Advertising and Communication (CDER) |
|
DDMS |
Division of Database Management and Services |
|
DDMS (CDER) |
Division of Database Management and Services (CDER) |
|
DDMSS (CDER) |
Division of Data Management Services and Solutions (CDER) |
|
DDOM |
Division of Disclosure and Oversight Management |
|
DDOM (CBER) |
Division of Disclosure and Oversight Management (CBER) |
|
DDOP |
Division of Drug Oncology Products (FDA) |
|
DDOP (CDER) |
Division of Drug Oncology Products (CDER) |
|
DDPS |
Detailed Description of the Pharmacovigilance System |
|
DDR |
Donor Deferral Registry |
|
DDRE |
Division of Drug Risk Evaluation |
|
DDRE (CDER) |
Division of Drug Risk Evaluation (CDER) |
|
DDS |
Deputy Director for Safety (CDER) |
|
DDSL |
Division Data Standards Leads |
|
DDSLWG |
Division Data Standards Leads Working Group |
|
DDSPC |
Division of Dietary Supplement Programs and Compliance |
|
DDSPC (CFSAN) |
Division of Dietary Supplement Programs and Compliance (CFSAN) |
|
DE (CBER) |
Division of Epidemiology (CBER) |
|
DE (CFSAN) |
Division of Enforcement (CFSAN) |
|
DEA |
Drug Enforcement Administration (U.S. Department of Justice) |
|
DEB |
Dairy and Egg Branch |
|
DEB (CFAN) |
Dairy and Egg Branch (CFSAN) |
|
DEC (CFSAN) |
Division of Education and Communication (CFSAN) |
|
DEEM |
Dietary Exposure Evaluation Model (Durango Software LLC) |
|
DEHP |
Di(2-ethylhexyl)phthalate |
|
DEIO (ORA) |
Division of Emergency and Investigational Operations (ORA) |
|
DEMO (CDRH) |
Division of Ethics and Management Operations (CDRH) |
|
DEN |
Drug Experience Network |
|
DEOD |
Dental, Ear, Nose, Throat, and Ophthalmic Devices Branch |
|
DEOD (CDRH) |
Dental, Ear, Nose, Throat and Ophthalmic Devices Branch (CDRH) |
|
DEP |
Data Evaluation Project |
|
DEPI |
Division of Ethics and Program Integrity |
|
DEPI |
Division of EPIpidemiology |
|
DEPI (CBER) |
Division of Ethics and Program Integrity (CBER) |
|
DEPI (CDER) |
Division of Epidemiology (CDER) |
|
DER |
Drug Experience Report |
|
DES |
diethyl sulphate |
|
DES |
Drug Eluting Stent |
|
DES (CVM) |
Division of Epidemiology and Surveillance (Center for Veterinary Medicine) |
|
DES (OC) |
Division of Engineering Services (Immediate Office of the Commissioner) |
|
DESE |
Division of Electrical and Software Engineering |
|
DESE (CDRH) |
Division of Electrical and Software Engineering (CDRH) |
|
DESI |
Drug Efficacy Study Implementation Notice (Food & Drug Administration, to evaluate drugs in use befaore 1962) |
|
DETTD |
Division of Emerging and Transfusion Transmitted Diseases |
|
DETTD (CBER) |
Division of Emerging and Transfusion Transmitted Diseases (CBER) |
|
DEV |
DEVice Registration Number |
|
DFARS |
Drug Firm Annual Registration Status |
|
DFAS |
Defense Finance & Accounting Service |
|
DFCN (CFSAN) |
Division of Food Contact Notifications (CFSAN) |
|
DFEM (NCTR) |
Division of Facilities Engineering and Maintenance (NCTR) |
|
DFFI |
Division of Foreign Field Investigations (ORA) |
|
DFLSC (CFSAN) |
Division of Food Labeling, Standards, and Compliance (CFSAN) |
|
DFM (NCTR) |
Division of Financial Management (NCTR) |
|
DFO |
Designated Federal Official |
|
DFO (OC) |
Division of Field Operations (OC) |
|
DFOI (OC) |
Division of Freedom of Information (OC) |
|
DFPG (CFSAN) |
Division of Field Programs and Guidance (CFSAN) |
|
DFPP (CFSAN) |
Division of Food Processing and Packaging (Chicago, Illinois) (CFSAN) |
|
DFPST (CFSAN) |
Division of Food Processing Science and Technology (CFSAN) |
|
DFRM |
Drug Facility Registration Module (FURLS) |
|
DFS |
Division File System |
|
DFS (ORA) |
Division of Field Science (ORA) |
|
DFSR |
Division of Federal-State Relations (Office of Regulatory Affairs) |
|
DGFPS |
Direccion General de Farmacia y Productos Sanitarios (Directorate General of Pharmacy and Sanitary Products) (Spain) |
|
DGP (CDER) |
Division of Gastroenterology Products (CDER) |
|
DGRND (CDRH) |
Division of General, Restorative and Neurological Devices (CDRH) |
|
DGRT (NCTR) |
Division of Genetic and Reproductive Toxicology (NCTR) |
|
DGSS (CFSAN) |
Division of General Scientific Support (CFSAN) |
|
DH (CBER) |
Division of Hematology (CBER) |
|
DHC |
dioxin health certificate (ORA AofC code) |
|
DHCP |
Dynamic Host Configuration Protocol |
|
DHCP |
Dear Health Care Professional |
|
DHF |
Design History File |
|
DHFS (CVM) |
Division of Human Food Safety (CVM) |
|
DHHS |
Department of Health and Human Services (U.S.) |
|
DHR |
Device History Record |
|
DHRD (ORA) |
Division of Human Resources Development (ORA) |
|
DHS |
Department of Homeland Security (U.S.) |
|
DHSS |
Department of Health and Social Security (U.K.) |
|
DHT (CBER) |
Division of Human Tissues (CBER) |
|
DI |
Diabetes Insipidus |
|
DI |
De-Ionized |
|
DIA |
Drug Information Association |
|
DIA |
Defense Intelligence Agency (USA) |
|
DIAM |
Division of Imaging and Applied Mathematics |
|
DIAM (CDRH) |
Division of Imaging and Applied Mathematics (CDRH) |
|
DIB |
Director, Investigations Branch |
|
DIBD |
Development International Birth Date |
|
DIC |
disseminated intravascular coagulation |
|
DICOM |
Digital Imaging and Communications in Medicine |
|
DID |
Department of Infectious Diseases |
|
DID (CBER) |
Division of Information Development (CBER) |
|
DIDP (CBER) |
Division of Information Disclosure Policy (CDER) |
|
DIHD (CDRH) |
Division of Immunology and Hematology Devices (CDRH) |
|
DILI |
drug-induced liver injury |
|
DIMS |
Data Information Management Staff |
|
DIMS (CFSAN) |
Data Information Management Staff (CFSAN) |
|
DIMS (OC) |
Division of Infrastructure Management and Services (OC) |
|
DIN |
Drug Identification Number |
|
DIO (CBER) |
Division of Information Operations (CBER) |
|
DIO (OC) |
Division of Infrastructure Operations (OC) |
|
DIOP (ORA) |
Division of Import Operations and Policy (ORA) |
|
DIRM (CFSAN) |
Division of Information Resources Management (CFSAN) |
|
DIS (CBER) |
Division of Inspections and Surveillance (CBER) |
|
DIS (CDER) |
Division of Information Services (CDER) |
|
DIT (CDRH) |
Division of Information Technology (Center for Drug Evaluation and Research) |
|
DIT (NCTR) |
Division of Information Technology (National Center for Toxicological Research) |
|
DIVBT (CFSAN) |
Division of In Vitro and Biochemical Toxicology (CFSAN) |
|
DJD |
Degenerative Joint Disease |
|
DKA |
Diabetic Ketoacidosis |
|
DL |
Deciliter |
|
DLAM |
Division of Laboratory Animal Medicine |
|
DLI |
Donor Lymphocyte Infusion |
|
DLPS |
Division of Labeling and Program Support |
|
DLPS (CDER) |
Division of Labeling and Program Support (CDER) |
|
DLR |
Drug Listing Rule |
|
DLS |
Diagnostic Laboratory Services |
|
DLS |
Document Logging System |
|
DM |
Diabetes mellitus |
|
DM (CFSAN) |
Division of Microbiology (CFSAN) |
|
DM (CFSAN) |
Division of Mathematics (CFSAN) |
|
DM (NCTR) |
Division of Microbiology (NCTR) |
|
DMA |
Danish Medicines Agency |
|
DMA (CDER) |
Division of Monoclonal Antibodies (CDER) |
|
DMARD |
disease-modifying antirheumatic drug |
|
DMARDS |
disease-modifying antirheumatic drug |
|
DMAT |
Disaster Medical Assistance Team |
|
DMAT |
Division of Manufacturers Assistance and Training |
|
DMAT (CBER) |
Division of Manufacturers Assistance and Training (CBER) |
|
DMB |
Dockets Management Branch |
|
DMB (CDER) |
Division of Management and Budget (CDER) |
|
DMB (CFSAN) |
Division of Molecular Biology (CFSAN) |
|
DMC |
Data Monitoring Committee |
|
DMD (CDRH) |
Division of Microbiology Devices (CDRH) |
|
DME |
Durable Medical Equipment |
|
DME (NCTR) |
Division of Molecular Epidemiology (NCTR) |
|
DMEP (CDER) |
Division of Metabolism and Endocrinology Products (CDER) |
|
DMEPA (CDER) |
Division of Medical Error Prevention and Analysis |
|
DMETS (CDER) |
Division of Medical Errors and Technical Support (CDER) |
|
DMF |
Drug Master File |
|
DMIHP (CDER) |
Division of Medical Imaging and Hematology Products (CDER) |
|
DMIP |
Division of Medical Imaging Products (CDER) |
|
DMIRDP (CDER) |
Division of Medical Imaging and Radiopharmaceutical Drug Products (CDER) |
|
DMO (CFSAN) |
Division of Management Operations (CFSAN) |
|
DMO (ORA) |
Division of Management Operations (ORA) |
|
DMPQ (CBER) |
Division of Manufacturing and Product Quality (CBER) |
|
DMPQ (CDER) |
Division of Manufacturing and Product Quality (CDER) |
|
DMQRP (CDRH) |
Division of Mammography Quality and Radiation Programs (CDRH) |
|
DMR |
Device Master Record |
|
DMS (CDER) |
Division of Management Services (CDER) |
|
DMS (CFSAN) |
Division of Microbiological Studies (CFSAN) |
|
DMS (OC) |
Division of Management Systems (OC) |
|
DMSO |
chloroform/2-propanol/dimethylsulfoxide |
|
DMST (CFSAN) |
Division of Market Studies (CFSAN) |
|
DMT (CVM) |
Division of Manufacturing Technologies (CVM) |
|
DNA |
Deoxyribose Nucleic Acid |
|
DNCE (CDER) |
Division of Nonprescripton Clinical Evaluation (CDER) |
|
DNDLC (CDER) |
Division of New Drugs and Labeling Compliance (CDER) |
|
DNP (CDER) |
Division of Neurology Products (Center for Drug Evaluation and Research) |
|
DNP (CFSAN) |
Division of Natural Products (Center for Food Safety and Applied Nutrition) |
|
DNPL (CFSAN) |
Division of Nutrition Programs and Labeling (Center for Food Safety and Applied Nutrition) |
|
DNR |
Do Not Resuscitate |
|
DNRD |
Division of Nonprescription Regulation Development |
|
DNRD (CDER) |
Division of Nonprescription Regulation Development (CDER) |
|
DNS |
Domain Name Server |
|
DNT (NCTR) |
Division of Neurotoxicology (NCTR) |
|
DOD |
United States Department of Defense |
|
DODAAC |
Department Of Defense Activity Address Code |
|
DODP (CDER) |
Division of Oncologic Drug Products (CDER) |
|
DOE A (CDRH) |
Division of Enforcement A (CDRH) |
|
DOE B (CDRH) |
Division of Enforcement B (CDRH) |
|
DOED (CDRH) |
Division of Ophthalmic, Ear, Nose and Throat Devices (CDRH) |
|
DOI |
Department of the Interior (US) |
|
DOJ |
Department of Justice (US) |
|
DONED |
Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices (CDRH) |
|
DOT (CFSAN) |
Division of Toxicology (CFSAN) |
|
DP |
Drug Product |
|
DP (CDRH) |
Division of Physics (Center for Devices and Radiological Health) |
|
DP (NCTR) |
Division of Planning (National Center for Toxicological Research) |
|
DPA |
Division of Pharmaceutical Analysis |
|
DPA I |
Division of Pre-marketing Assessment I |
|
DPA I (CDER) |
Division of Pre-marketing Assessment I (CDER) |
|
DPA II |
Division of Pre-marketing Assessment II |
|
DPA II (CDER) |
Division of Pre-marketing Assessment II (CDER) |
|
DPAF |
Division of Planning, Analysis, and Finance |
|
DPAMS |
Division of Pre-marketing Assessment III and Manufacturing Science |
|
DPAMS (CDER) |
Division of Pre-marketing Assessment III and Manufacturing Science (CDER) |
|
DPAP |
Division of Pulmonary and Allergy Products |
|
DPAP (CDER) |
Division of Pulmonary and Allergy Products (CDER) |
|
DPC-PTR Act |
Drug Price Competition and Patent Trade Restoration Act of 1984 |
|
DPCPSI |
Division of Program Coordination, Planning, and Strategic Initiatives |
|
DPD (CVM) |
Division of Production Drugs (CVM) |
|
DPD (OC) |
Division of Portfolio Development (OC) |
|
DPDD (CDER) |
Division of Pediatric Drug Development (CDER) |
|
DPDFS |
Division of Plant and Dairy Food Safety |
|
DPDFS (CFSAN) |
Division of Plant and Dairy Food Safety (CFSAN) |
|
DPE (CDER) |
Division of Post-marketing Development (CDER) |
|
DPEB |
Division of Planning, Evaluation, and Budget |
|
DPEB (CBER) |
Division of Planning, Evaluation and Budget (CBER) |
|
DPEM |
Division of Planning, Evaluation, and Management |
|
DPEM (ORA) |
Division of Planning, Evaluation and Management (ORA) |
|
DPEPOS (CFSAN) |
Division of Programs and Enforcement Policy (OS) (CFSAN) |
|
DPFRM |
Division of Planning and Financial Resources Management |
|
DPFRM (CFSAN) |
Division of Planning and Financial Resources Management (CFSAN) |
|
DPHB (CFSAN) |
Division of Public Health and Biostatistics (CFSAN) |
|
DPIC (CFSAN) |
Division of Pesticides and Industrial Chemicals (CFSAN) |
|
DPL |
Drug Product Licensing (Canada) |
|
DPMU |
Disaster Portable Morgue Unit |
|
DPP |
Division of Psychiatry Products |
|
DPP (CDER) |
Division of Psychiatry Products (CDER) |
|
DPPS |
Division of Plant Product Safety |
|
DPPS (CFSAN) |
Division of Plant Product Safety (CFSAN) |
|
DPQ (CBER) |
Division of Product Quality (CBER) |
|
DPQR (CDER) |
Division of Product Quality Research (CDER) |
|
DPR |
Division of Petition Review |
|
DPR (CFSAN) |
Division of Petition Review (CFSAN) |
|
DPRF |
Drug Product Reference File |
|
DPS |
Division of Post-marketing Surveillance |
|
DPS (CBER) |
Division of Program Services (CBER) |
|
DPS (CDRH) |
Division of Post-marketing Surveillance (CDRH) |
|
DPS (CFSAN) |
Division of Program Services (CFSAN) |
|
DPT |
Diphtheria, Pertussis And Tetanus |
|
DQ |
Design Quality |
|
DQRS |
Drug Quality Reporting System |
|
DRA |
Division of Risk Assessment |
|
DRA (CFSAN) |
Division of Risk Assessment (CFSAN) |
|
DRARD |
Division of Reproductive Abdominal and Radiological Devices |
|
DRARD (CDRH) |
Division of Reproductive, Abdominal and Radiological Devices (CDRH) |
|
DRAT |
Division of Research and Applied Technology |
|
DRAT (CFSAN) |
Division of Research and Applied Technology (CFSAN) |
|
DRB |
Devices Review Branch |
|
DRB (CBER) |
Devices Review Branch (CBER) |
|
DRC (CVM) |
Division of Residue Chemistry (CVM) |
|
DRF |
Dose Range Findings |
|
DRFDD |
Deputy Regional Food and Drug Director |
|
DRFDD (ORA) |
Deputy Regional Food and Drug Director (ORA) |
|
DRGUD |
Division of Reproductive, Gastrorenal and Urology Devices (CDRH) |
|
DRI |
Daily Reference Intake |
|
DRISK (CDER) |
Divison of Risk Management (CDER) |
|
DRLM |
Device Registration and Listing Module (FURLS) |
|
DRLS |
Drug Registration and Listing System |
|
DRM (CDER) |
Division of Records Management (CDER) |
|
DRM (OC) |
Division of Resource Management (OC) |
|
DRMO (CDRH) |
Division of Risk Management Operations (CDRH) |
|
DRMP (CDER) |
Division of Review Management and Policy (CDER) |
|
DRP (CBER) |
Division of Regulations and Policy (CBER) |
|
DRP I (CDER) |
Division of Regulatory Policy I (CDER) |
|
DRP II (CDER) |
Division of Regulatory Policy II (CDER) |
|
DRPM |
Dispute Resolution Project Manager |
|
DRR (NCTR) |
Deputy Director for Research (NCTR) |
|
DRS |
Drug-Resistance Survey |
|
DRUP |
Division of Reproductive and Urologic Products |
|
DRUP (CDER) |
Division of Reproductive and Urologic Products (CDER) |
|
DRV |
Daily Reference Value |
|
DS |
Drug Substance |
|
DS (CVM) |
Division of Surveillance (CVM) |
|
DSAC |
Division of Scientific Advisors and Consultants |
|
DSATOS (CFSAN) |
Division of Science and Applied Technology (OS) (CFSAN) |
|
DSB |
Drug Safety Oversight Board |
|
DSC |
Drug Safety Communication |
|
DSCI (OC) |
Division of Systems, Compliance and IMPAC (OC) |
|
DSDB |
Diagnostic and Surgical Devices Branch |
|
DSDB (CDRH) |
Diagnostic and Surgical Devices Branch (CDRH) |
|
DSFM (CDRH) |
Division of Solid and Fluid Mechanics (CDRH) |
|
DSHEA |
Dietary Supplement and Health Education Act of 1994 |
|
DSI (CDER) |
Division of Scientific Investigation (CDER) |
|
DSM |
Data Standards Manual |
|
DSMB |
Data Safety Monitoring Board |
|
DSMICA |
Division of Small Manufacturers, International and Consumer Assistance (FDA) |
|
DSMICA (CDRH) |
Division of Small Manufacturers, International and Consumer Assistance (CDRH) |
|
DSORD |
Division of Surgical, Orthopedic, and Restorative Devices |
|
DSP (OC) |
Division of Strategic Projects (OC) |
|
DSPB |
Data Standards Program Board |
|
DSPTP (CDER) |
Division of Special Pathogen and Transplant Products (CDER) |
|
DSRCS (CDER) |
Division of Surveillance, Research and Communication Support (CDER) |
|
DSRIT |
Dietary Supplement Regulations Implementation Team |
|
DSRIT (CFSAN) |
Dietary Supplement Regulations Implementation Team (CFSAN) |
|
DSS |
Decision Support System |
|
DSS (CDRH) |
Division of Surveillance Systems (CDRH) |
|
DSSC |
Dietary Supplements Subcommittee |
|
DSST (CFSAN) |
Division of Seafood Science and Technology (CFSAN) |
|
DSUR |
Development Safety Update Report |
|
DTaP |
diphtheria, tetanus and acellular pertussis |
|
DTBE |
Division of Tuberculosis Elimination |
|
DTBIMP (CDER) |
Division of Therapeutic Biological Internal Medicine Products (CDER) |
|
DTBOP (CDER) |
Division of Therapeutic Biological Oncology Products (CDER) |
|
DTC |
Direct-to-Consumer (drug advertising) |
|
DTD (CDER) |
Division of Training and Development (CDER) |
|
DTDFA |
Division of Therapeutic Drugs for Food Animals |
|
DTDFA (CVM) |
Division of Therapeutic Drugs for Food Animals (CVM) |
|
DTDNFA |
Division of Therapeutic Drugs for Non-food Animals |
|
DTDNFA (CVM) |
Division of Therapeutic Drugs for Non-food Animals (CVM) |
|
DTNPS (CFSAN) |
Division of Toxicology and Nutrition Product Studies (CFSAN) |
|
DTP |
Direct-to-Patient |
|
DTP (CDER) |
Division of Therapeutic Proteins (CDER) |
|
DTS |
Distribution Tracking System |
|
DUNS |
Data Universal Numbering System |
|
DUPSA (CDRH) |
Division of Device User Programs and System Analysis (CDRH) |
|
DUR |
Drug Utilization Review |
|
DURSA |
Data Use and Reciprocal Support Agreement |
|
DUSM |
Deputy United States Marshal (U.S. Department of Justice) |
|
DV |
Daily Values |
|
DVA (CFSAN) |
Division of Virulence Assessment (CFSAN) |
|
DVD |
Digital Video Disc |
|
DVH |
Division of Viral Hepatitis (CDC) |
|
DVM |
Doctor of Veterinary Medicine |
|
DVP (CBER) |
Division of Viral Products (CBER) |
|
DVPS (CVM) |
Division of Veterinary Product Safety |
|
DVR |
Deviation Variance Report |
|
DVRPA (CBER) |
Division of Vaccines and Related Product Applications (CBER) |
|
DVS (CBER) |
Division of Veterinary Services (CBER) |
|
DVS (NCTR) |
Division of Veterinary Services (NCTR) |
|
DVT |
Deep Venous Thrombosis |
|
DWPE |
Detention without Physical Examination |
|
DX |
Diagnosis |
|
DXA |
Dual-energy X-ray Absorptiometry test |
|
E-ARCH |
Extended Adult Residential Care Home |
|
e-CRF |
electronic case report form |
|
E2B |
FDA Working Group that defined Efficacy Topics' Data Elements for Transmission of Adverse Drug Reactions Reports |
|
EA |
Environmental Assistance |
|
EAA |
essential amino acidsolution |
|
EAB |
Ethics Advisory Board |
|
EAB (CFSAN) |
Exposure Assessment Branch (CFSAN) |
|
EAC |
Expert Advisory Committee (Canada) |
|
eANDA |
Electronic Abbreviated New Drug Application |
|
EAR |
Export Administration Regulations |
|
EAS |
Emergency Alert System |
|
EAS (CDER) |
Enterprise Architecture Staff (CDER) |
|
EASE |
Enterprise Administrative Support Environment |
|
EB (CDRH) |
Epidemiology Branch (CDRH) |
|
EB (NCTR) |
Engineering Branch (NCTR) |
|
eBPDR |
electronic biological product deviation reporting |
|
EBS |
Emergency Broadcast System |
|
EC |
European Community |
|
ECBS |
Expert Committee on Biological Standardization (WHO) |
|
eCDT |
Electronic Common Technical Document |
|
ECE |
Economische Commissie voor Europa (United Nations) (Dutch: Economic Commission for Europe) |
|
ECG |
Electrocardiogram |
|
ECL |
Electrochemiluminescence |
|
ECP |
Emergency Contraception Pill |
|
eCRF |
Electronic Case Report Form |
|
ECRI |
Emergency Care Research Institute (no longer uses name initials only) |
|
ECRS (CFSAN) |
Emergency Coordination and Response Staff (CFSAN) |
|
ECS (OC) |
Economics Staff (OC) |
|
ECT |
Electro-Convulsive Therapy |
|
ECT (CFSAN) |
Economics Team (CFSAN) |
|
eCTD |
Electronic Common Technical Document |
|
ECU |
European Currency Unit |
|
ED |
Effective Dose |
|
EDI |
Electronic Data Interchange |
|
EDIFACT |
Electronic Data Interchange for Administration, Commerce, and Transportation |
|
EDIPI |
Electronic Data Interchange Personal Identifier |
|
EDKB |
Endocrine Disrupter Knowledge Base |
|
EDMF |
European Drug Master File |
|
EDMS |
Electronic Document Management System |
|
EDQM |
European Directorate for the Quality of Medicines |
|
EDRG |
Early Detection Research Group |
|
eDRLS |
Electronic Drug Registration and Listing Systems |
|
EEA |
European Economic Area |
|
EEC |
European Economic Community (predecessor of the European Union|EU) |
|
EEG |
Electro-EncephaloGram |
|
EEO |
Equal Employment Opportunity |
|
EEO (CFSAN) |
Equal Employment Opportunity Office (CFSAN) |
|
EEO (NCTR) |
Equal Employment Opportunity Staff (NCTR) |
|
EEOC |
Equal Employment Opportunity Commission |
|
EEPS |
Electronic Entry Processing System |
|
EER |
Establishment Evaluation Request |
|
EES |
Establishment Evaluation System |
|
EFD |
Engineering Flow Diagram |
|
EFGCP |
European Forum on Good Clinical Practice |
|
EFOIA |
Electronic Freedom of Information Act |
|
EFPIA |
European Federation of Pharmaceutical Industries and Associations |
|
EFT |
Electronic Funds Transfer |
|
EFTA |
European Free Trade Association (Geneva) |
|
EGA |
European Generics Medicines Association |
|
EH & S |
environmental health and safety |
|
EH&S |
Environmental Health and Safety |
|
EHPAS (NCTR) |
Environmental Health and Program Assurance Staff (NCTR) |
|
EHR |
Electronic Health Record |
|
EHRP |
Enterprise Human Resources and Payroll System |
|
EHSB |
Environmental Health Services Branch |
|
eIDE |
Electronic Investigational Device Exemption |
|
EIEIO |
External Interference Engineering Investigations Office |
|
EIF |
Expected Investment Fund |
|
EIND |
Electronic Investigational New Drug Application (US Food and Drug Administration) |
|
EINECS |
European Inventory Of Existing Commercial Chemical Substances |
|
EIS (OC) |
Ethics and Integrity Staff (OC) |
|
EKG |
electrocardiogram |
|
ELDU |
Extra-Label Drug Use |
|
eLEXNET |
Electronic Laboratory Exchange Network |
|
ELINCS |
European List of Notified Chemical Substances |
|
ELIPS |
Electronic Labeling Information Processing System |
|
ELISA |
enzyme-linked immunosorbent assay |
|
eLIST |
electronic listing system |
|
ELPS |
establishment licensing and product surveillance |
|
ELS |
Establishment License Supplement |
|
EMAC |
Emergency Management Assistance Compact |
|
EMBS |
Engineering in Medicine and Biology Society (IEEE) |
|
EMC |
Electromagnetic Compatibility |
|
EMEA |
European Medicines Agency (formerly European Medicines Evaluation Agency) |
|
EMI |
Electro-Magnetic Interference |
|
EML |
Environmental Measurement Laboratory |
|
EMOPS (OC) |
Office of Emergency Operations (OC) |
|
EMV |
eye-motor-verbal (Glasgow coma scale) |
|
ENG (OC) |
Engineering Team (OC) |
|
ENL |
Erythema Nodosum Leprosum |
|
ENTB (CDRH) |
Ear, Nose, and Throat Devices Branch (CDRH) |
|
EO |
Executive Order |
|
EOC |
Emergency Operations Center (FDA) |
|
eOFP |
electronic Official Personnel File |
|
EOP1 |
End-Of-Phase 1 |
|
EOP2 |
End-Of-Phase 2 |
|
EORTC |
European Organisation for Research and Treatment of Cancer |
|
EOS |
End of Study |
|
EOS (CDER) |
Executive Operations Staff (CDER) |
|
EOS (ORA) |
Executive Operations Staff (ORA) |
|
EP |
European Pharmacopoeia |
|
EPA |
Environmental Protection Agency (US) |
|
EPAR |
European Public Assessment Report |
|
EPC |
Evidence-based Practice Center |
|
EPD (CDRH) |
Electronic Product Devices Branch (CDRH) |
|
EPFA |
European Plasma Fractionation Association |
|
EPI |
ESSENTIAL PRESCRIBING INFORMATION |
|
EPIA |
Egg Products Inspection Act |
|
EPL |
Effective Patent Life |
|
EPMS |
Employee Performance Management System |
|
EPO |
European Patent Office |
|
EPRG |
European Pharmacovigilance Research Group |
|
EPRS |
Establishment Product Registration System |
|
EPT (CFSAN) |
Epidemiology Team (CFSAN) |
|
ER |
Extended-Release |
|
ER/ES |
Electronic Records/Electronic Signatures |
|
ERB (CFSAN) |
Elemental Research Branch (CFSAN) |
|
ERC |
Engineering Research Center |
|
ERCP |
Endoscopic Retrograde Cholangio-pancreatography Procedures |
|
EREA |
Export Reform and Enhancement Act of 1996 |
|
ERIC |
Employee Resource Information Center |
|
ERP |
Enterprise Resource Planning |
|
ERR |
Entry Review Recommended |
|
ERSB |
Emergency Response and Surveillance Branch |
|
ERSB (CFSAN) |
Emergency Response and Surveillance Branch (CFSAN) |
|
ERSR |
Electronic Regulatory Submissions and Review |
|
ERT |
Emergency Response Team |
|
ES |
Effect Size |
|
ESB |
Enterprise Systems Branch |
|
ESB (ORA) |
Enterprise Systems Branch (ORA) |
|
ESC |
Electronic Submission Coodinator |
|
ESD |
Electrostatic Discharge |
|
ESF |
Emergency Support Function |
|
ESG |
Electronic Submissions Gateway |
|
ESIG |
Electronic Signature |
|
ESM |
Electronic Secure Messaging |
|
ESRA |
European Society of Regulatory Affairs |
|
ESS (CBER) |
Executive Secretariat Team (CBER) |
|
ESS (NCTR) |
Executive Secretariat Staff (NCTR) |
|
ET (CFSAN) |
Education Team (CFSAN) |
|
ETA |
EASE (Enterprise Administrative Support Environment) Time and Attendance module |
|
ETASU |
Elements To Assure Safe Use |
|
ETOH |
Ethyl Alcohol (Ethanol) |
|
ETR |
Electronic National Tuberculosis Registry |
|
EUCOMED |
EUropean COnfederation of MEDical Devices Associations |
|
EUP |
Experimental Use Permit |
|
EVA |
Entry Validation Application |
|
EVS (OC) |
Evaluation Staff (OC) |
|
EWG |
Expert Working Group |
|
FA |
Filing Action |
|
FAAN |
Food Allergy and Anaphylaxis Network |
|
FACA |
Federal Advisory Committee Act 1972 |
|
FACD |
Food Additives and Chemicals Division |
|
FACS |
Food Advisory Committee Staff |
|
FACS (CFSAN) |
Food Advisory Committee Staff (CFSAN) |
|
FACT |
Functional Assessment of Cancer Therapy--General |
|
FACTS@FDA |
system for electronically communicating approved drug labeling and for disseminating prescribing information |
|
FAEMS |
Foods Adverse Event Monitoring System |
|
FAERS |
FDA Adverse Event Reporting System |
|
FAHCT |
Foundation for Accreditation of Hematopoietic Cell Therapy |
|
FAI |
Further Action Indicated |
|
FAIR |
Federal Activities Inventory Reform Act of 1998 |
|
FALCPA |
Food Allergen Labeling and Consumer Protection Act |
|
FAM |
Foreign Affairs Manual |
|
FAMe |
Formula for Achieving Managerial Excellence |
|
FAN |
Food Allergy Network |
|
FAO |
Food and Agriculture Organization of the United Nations |
|
FAPMC |
Food Animal Production Medicine Consortium |
|
FAQ |
Frequently Asked Questions (sometimes Pronounced Fak) |
|
FAQD |
Frequently Asked Questions Database |
|
FARAD |
Food Animal Residue Avoidance Databank |
|
FARM |
Food Additives Regulatory Management System |
|
Farmindu stria |
Association of Italian Pharmaceutical Manufacturers |
|
FASA |
Federal Acquisition Streamlining Act (of 1994) |
|
FASAB |
Federal Accounting Standards Advisory Board |
|
faseb |
Federation of American Societies for Experimental Biology's |
|
FASS |
Federation of Animal Science Societies |
|
FAT |
Factory Acceptance Test |
|
FBI |
Federal Bureau of Investigation |
|
FBS |
fasting blood sugar |
|
FCCSET |
Federal Coordinating Council for Science, Engineering, and Technology |
|
FCE |
Food Canning Establishment number |
|
FCIC |
Federal Consumer Information Center |
|
FCLAA |
Federal Cigarette Labeling and Advertising Act of 1965 |
|
FCO |
Federal Coordinating Officer (in disaster areas) |
|
FCRDC |
Frederick Cancer Research and Development Center |
|
FD&C ACT |
Federal Food, Drug, and Cosmetic Act of 1938 |
|
FD-1932 |
FDA form, Veterinary Adverse Drug Reaction, lack of effectiveness, product defect report - Mandatory |
|
FD-1932a |
FDA form for veterinary adverse drug reaction, lack of effectiveness, product defect report - voluntary |
|
FD-2301 |
FDA form, Transmittal of Periodic Reports and Promotional Material for New Animal Drugs |
|
FD-483 |
FDA form, Written Notice of Deficiencies Found in Inspections |
|
FDA BLA |
Food and Drug Administration - Biologicals License Application |
|
FDA-WO |
Food and Drug Administration White Oak campus |
|
FDAAA |
Food and Drug Administration Amendments Act |
|
FDAGLOBE |
Gay, Lesbian, Bisexual, Transgender Employees of the Federal Government within FDA |
|
FDAMA |
Food and Drug Administration Modernization Act of 1997 |
|
FDARA |
Food and Drug Administration Revitalization Act |
|
FDAS |
Defense Finance and Accounting Services |
|
FDASIA |
Food and Drug Administration Safety and Innovation Act |
|
FDASS (OC) |
FDA Safety Staff (OC) |
|
FDC |
Food Drug and Cosmetic |
|
FDCA |
Federal Food, Drug, and Cosmetic Act of 1938 |
|
FDERA |
Food and Drug Export Reform and Enhancement Act of 1996 |
|
FDLI |
Food and Drug Law Institute |
|
FDOT (CFSAN) |
Food Defense Oversight Team (CFSAN) |
|
FEB |
Federal Executive Board |
|
FECA |
Federal Employee's Compensation Act |
|
FedGLOBE |
Gay, Lesbian, Bisexual, Transgender Employees of the Federal Government |
|
FEDRIP |
FEDeral Research In Progress Database |
|
FedRooms |
Federal Premier Lodging Program |
|
FEEA |
Federal Employee Assistance and Education Fund |
|
FEGLI |
Federal Employees Group Life Insurance |
|
FEHB |
Federal Employees Health Benefits |
|
FEHBP |
Federal Employees Health Benefits Program |
|
FEI |
FDA Establishment Identifier (ORA) |
|
FEMA |
Federal Emergency Management Agency |
|
FERC |
Federal Energy Regulatory Commission (U.S.) |
|
FERN |
Food Emergency Response Network |
|
FERS |
Federal Employees Retirement System |
|
FES (OC) |
Financial Enterprise Solutions (OC) |
|
FF |
Fogarty Fellow |
|
FFD & C |
Federal Food, Drug and Cosmetic Act of 1938 |
|
FFDCA |
Federal Food, Drug and Cosmetic Act of 1938 |
|
FFLA |
Family Friendly Leave Act |
|
FFRM |
Food Facility Registration Module (FURLS) |
|
FFS |
Fee-For-Service |
|
FGIS |
Comisión Federal para la Protección contra Riesgos Sanitarios (Federal Commission for the Protection Against Sanitary Risks) (Mexico) |
|
FHA |
Federal Health Architecture |
|
fhb |
Food and Health Bureau |
|
FHSA |
Federal Hazardous Substances Act (Consumer Product Safety Commission) |
|
FIC |
John E. Fogarty International Center |
|
FICEMS |
Federal Interagency Committee on Emergency Medical Services |
|
FIFO |
First In, First Out |
|
FIFR |
first-in-first reviewed |
|
FIH |
First-In-Human |
|
FII |
FarmIndustria Italy |
|
FIREBIRD |
Federal Investigator REegistry for BioInformatics Research Data |
|
FIRSt |
FDA Information Retrieval System |
|
FIS |
Field Information System |
|
FIT |
FDA Internet Improvement Team |
|
FLC |
Federal Laboratory Consortium |
|
FLETC |
Federal Law Enforcement Training Center |
|
FLQ |
Fluoroquinolone |
|
FLSA |
Fair Labor Standards Act |
|
FLSS (CFSAN) |
Food Labeling and Standards Staff (CFSAN) |
|
FLTCIP |
Federal Long Term Care Insurance Program |
|
FMB |
Financial Management Branch |
|
FMB (CDRH) |
Financial Management Branch (CDRH) |
|
FMECA |
failure modes, effects, and criticality analysis |
|
FML |
Firms Master List |
|
FMLA |
Family and Medical Leave Act of 1993 |
|
FMRI |
Functional Magnetic Resonance Imaging |
|
FMS |
Financial Management Service (U.S. Department of the Treasury) |
|
FNH |
Febrile Non-Hemolytic reaction |
|
FNS |
Food and Nutrition Service |
|
FOB |
Federal Office Building |
|
FOI |
Freedom of Information |
|
FOIA |
Freedom of Information Act |
|
FOIB (CDRH) |
Freedom of Information Branch (CDRH) |
|
FONSI |
Finding of no significant impact. See Environmental impact statement (US) |
|
FOP |
Financial Operating Plan |
|
FORCG |
Foodborne Outbreak Response Coordinating Group |
|
FORM 1932 |
Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report - Mandatory |
|
FORM 1932a |
Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report - Voluntary |
|
FORM 348 |
Sponsored Travel |
|
FORM 3500 |
Voluntary Reporting of Adverse Events |
|
FORM 3500A |
Mandatory Reporting of Adverse Events |
|
FORM 356V |
New Animal Drug Application |
|
FORM 482 |
Notice Of Inspection |
|
FORM 483 |
Written Notice Of Deficiencies Found In Inspections |
|
FOUO |
For Official Use Only |
|
FPA |
Food Products Association |
|
FPB |
Food Processing Branch (Chicago, Illinois) |
|
FPB (CDRH) |
Field Programs Branch (Center for Devices and Radiological Health) |
|
FPB (CFSAN) |
Field Programs Branch (Center for Food Safety and Applied Nutrition) |
|
FPBR |
Food Packaging Branch (Chicago, Illinois) |
|
FPBR (CFSAN) |
Food Packaging Branch (Chicago, Illinois) (CFSAN) |
|
FPET |
Food Processing Evaluation Team |
|
FPET (CFSAN) |
Food Processing Evaluation Team (CFSAN) |
|
FPIF |
Finnish Pharmaceutical Industry Association |
|
FPL |
Final Printed Labeling |
|
FPLA |
Fair Packaging and Labeling Act of 1967 |
|
FPLP |
Federal Premier Lodging Program |
|
FPS |
Federal Protective Service |
|
FPVST |
Facilities Planning and Voice Services Team |
|
FPVST (OC) |
Facilities Planning and Voice Services Team (OC) |
|
FQ |
Fluoroquinolone |
|
FQHC |
Federally-Qualified Health Center |
|
FQPA |
Food Quality Protection Act of 1996 |
|
FR |
Federal Register |
|
Fr.P. |
Pharmacopee Francaise (French Pharmacopoeia) |
|
FRAC |
FDA Research Animal Council |
|
FRDTS |
Federal Register Document Tracking System |
|
FRP |
Federal Response Plan (FEMA) |
|
FSA |
Farm Service Agency (USDA) |
|
fsanz |
Food Standards Australia New Zealand's |
|
FSH |
Follicular Stimulating Hormone |
|
FSIS |
Food Safety and Inspection Service |
|
FSMS |
Food Safety Management System |
|
FSPS (ORA) |
Federal-State Program Staff (ORA) |
|
FSTA |
federal supervisory travel approver |
|
FT (OC) |
Financial Team (OC) |
|
FTB (CFSAN) |
Food Technology Branch (CFSAN) |
|
FTC |
Federal Trade Commission (U.S.) |
|
FTCA |
Federal Trade Commission Act |
|
FTE |
Full-Time Equivalent |
|
FTIM |
first time in man |
|
FTP |
File Transfer Protocol |
|
FTR |
Federal Travel Regulations |
|
FTS |
Federal Telecommunications System |
|
FTT |
Failure To Thrive |
|
FU |
Farmacopea Ufficiale (Italian Pharmacopoeia) |
|
FURLS |
FDA Uniform Registration & Listing System |
|
FWP |
Federal Women's Program |
|
FX |
Fracture |
|
FY |
Fiscal Year |
|
FYI |
For Your Information |
|
G-MED (LNE) |
Groupfor Medical Device Assessment (Laboratoire National de Metrologie et d'Essias) |
|
GAAP |
Greater Access to Affordable Pharmaceuticals Act of 2003 |
|
GADPTRA |
Generlc Animal Drug and Patent Term Restoration Act |
|
GAO |
Government Accountability Office [formerly the General Accounting Office] |
|
GAP |
Good Agricultural Practice |
|
GARR |
Grants Application Review Request |
|
GAT |
genome amplification testing |
|
GATT |
General Agreement of Tariffs and Trade |
|
GBL |
Government Bill of Lading |
|
GCBS |
Global Collaboration for Blood Safety (WHO) |
|
GCC |
Government Coordinating Council of the Food and Agriculture Sector |
|
GCLP |
Good Clinical Laboratory Practice |
|
GCP |
Good Clinical Practice |
|
GCPB I (CDER) |
Good Clinical Practice Branch I (CDER) |
|
GCPB II (CDER) |
Good Clinical Practice Branch II (CDER) |
|
GCPP (OC) |
Good Clinical Practice Program (OC) |
|
GCRC |
General Clinical Research Centers |
|
GCSL (CFSAN) |
Gulf Coast Seafood Laboratory (Dauphin Island, Alabama) (CFSAN) |
|
GDEA |
Generic Drug Enforcement Act of 1992 |
|
GDS |
Global Distribution System |
|
GDUF |
Generic Drug User Fees |
|
GEBAT |
Government Excess Baggage Authorization Ticket |
|
GeMCRIS |
Genetic Modification Clinical Research Information System (NIH) |
|
GEO |
Genetically Engineered Organism |
|
GEP |
Good Engineering Practice |
|
GG |
Goal Group |
|
GGP |
Good Guidance Practice |
|
GHC |
Group Health Cooperative |
|
GHDB (CDRH) |
General Hospital Devices Branch (CDRH) |
|
GHS |
Globally Harmonised System of Classification and Labelling of Chemicals |
|
GHTF |
Global Harmonization Task Force |
|
GI |
Gastrointestinal |
|
GIF |
Graphics Interchange Format |
|
GILS |
Government Information Locator Service |
|
GINAD |
Generic Investigational New Animal Drug file |
|
GIPSA |
Grain Inspection, Packers & Stockyards Administration (USDA) |
|
GIS |
Geographical Information System |
|
GLP |
Good Laboratory Practice |
|
GLPBB (CDER) |
Good Laboratory Practices and Bioequivalence Investigations Branch (CDER) |
|
GM |
Genetic Modification |
|
gma |
Grocery Manufacturers Association's |
|
GMDN |
Global Medical Device Nomenclature |
|
GME |
Graduate Medical Education |
|
GMID |
Global Market Information Database |
|
GMP |
Good Manufacturing Practice |
|
GOCO |
government-owned contractor-operated |
|
GOCRG |
Gastrointestinal and Other Cancer Research Group |
|
GOVCC |
government travel charge card |
|
GOVTRIP |
government travel website operated by Northrop Grumman |
|
GPEA |
Government Paperwork Elimination Act |
|
GPHA |
Generic Pharmaceutical Association |
|
GPP |
good programming practices |
|
GPRA |
Government Performance Results Act of 1993 |
|
GPRD |
General Practice Research Database |
|
GRAS |
Generally Recognized As Safe |
|
GRAS/E |
Generally Recognized As Safe and Effective |
|
GRASE |
Generally Recognized As Safe and Effective |
|
GRC |
Gerontology Research Center |
|
GRDB (CDRH) |
Gastroenterology and Renal Devices Branch (CDRH) |
|
GRN |
Generally Recognized as Safe Notification |
|
GRNs |
Generally Recognized as Safe Notifications |
|
GRP |
Good Review Practice |
|
GRS |
General Records Schedule |
|
GS |
General Schedule |
|
GSA |
U.S. General Services Administration |
|
GSDB (CDRH) |
General Surgery Devices Branch (CDRH) |
|
GSFA |
General Standard for Food Additives |
|
GSP |
Good Statistics Practice |
|
GT |
Gutta (drops) |
|
GTB (CBER) |
Gene Therapies Branch (CBER) |
|
GTIB (CBER) |
Gene Transfer and Immunogenicity Branch (CBER) |
|
GTIS |
Gene Therapy Information System |
|
GTL (NCTR) |
Genetic Toxicology Laboratory (NCTR) |
|
GU |
Genitourinary |
|
GUI |
Graphical User Interface (goo-ey) |
|
GWQAP |
Government Wide Quality Assurance Program |
|
GxP |
Good "x" Practices (x = any type of practice) |
|
GXT |
graded exercise tolerance (Stress test) |
|
HA |
Headache |
|
HAA |
Hepatitis-Associated Antigen |
|
HAART |
Highly Active Antiretroviral Therapy ヨ the name commonly given to combinations of anti-HIV drugs |
|
HAB (CFSAN) |
Hazard Assessment Branch (CFSAN) |
|
HAD |
Hospital Anxiety and Depression scale |
|
HAI |
Health Action International |
|
HAM/TSP |
HTLV-I-associated myelopathy / tropical spastic paraparesis |
|
HARTS |
Hoechst Adverse Reaction Terminology System |
|
HAV |
Hepatitis A Virus |
|
HAZMAT |
Hazardous Material |
|
HAZOP |
HAZard and OPerability analysis |
|
HBOC |
hemoblogin-based oxygen carrier |
|
HBOT |
Hyperbaric Oxygen Therapy |
|
HBP |
High Blood Pressure |
|
HCBW |
Home and Community-Based Waiver |
|
HCCN |
Health Center-Controlled Network |
|
HCDB (CDRH) |
Hematology and Cytology Devices Branch (CDRH) |
|
HCFA |
Health Care Financing Administration |
|
HCG |
Human Chorionic Gonadotropin |
|
HCI |
Human-Computer Interaction |
|
HCO |
Health Care Organization |
|
HCP |
HealthCare Provider |
|
HCPCS |
HCFA (Health Care Financing Administration) Common Procedure Coding System |
|
HCT |
Hematocrit |
|
HCT/P |
human cellular and tissue-based products |
|
HCTERS |
Human Cell and Tissue Establishment Registration System |
|
HCTRS |
Human Cell and Tissue Establishment Registration System (usually seen as HCTERS) |
|
HCTZ |
Hydrochlorothiazide |
|
HDC |
High-Dose Chemotherapy |
|
HDE |
Humanitarian Use Exemption |
|
HDF |
mail code for CDER (Center for Drug Evaluation and Research) |
|
HDL |
High-Density Lipoprotein (a type of cholesterol) |
|
HDP |
Hydroxymethylene Di-Phosphonate |
|
hdpe |
High Density Polyethylene Electrical |
|
HEO |
Hispanic Employee Organization |
|
HEPA |
High-Efficiency Particulate Air filter |
|
hERG |
human ether-a-go-go gene |
|
HFA |
HydroFluoroAlkane |
|
HFD |
Headquarters, FDA Drug; mail code for Center for Drug Evaluation and Research |
|
HFEB (CDRH) |
Human Factors Engineering Branch (CDRH) |
|
hfes |
Human Factors and Ergonomics Society's |
|
HFS |
Headquarters, FDA Safety; mail code for Center for Food Safety and Applied Nutrition |
|
HFZ |
Headquarters, FDA code Z; mail code for Center for Devices and Radiological Health |
|
HGB |
Hemoglobin |
|
HHI |
Herth Hope Index |
|
HHMI |
Howard Hughes Medical Institute |
|
HHS |
U.S. Department of Health and Human Services |
|
HHS SERT |
Health and Human Services Secretary's Emergency Response Team |
|
HIBCC |
Health Industry Business Communication Council |
|
HIDE |
High Impact Data Elements |
|
HIM |
Health Information Management |
|
HIMA |
Health Industry Manufacturers Association |
|
HIPAA |
Health Insurance Portability and Accountability Act of 1996 |
|
HIRS |
Health Information Resources Service |
|
HISPC |
Health Information Security and Privacy Collaboration |
|
HITSP |
Health Information Technology Standards Panel |
|
HL7 |
Health Level 7 (a not-for-profit ANSI-accredited standards-developing organization (SDO) |
|
HLBT |
Heat Labile Bacterial Toxins |
|
HLGT |
high level group term |
|
HMO |
Health Maintenance Organization |
|
HNK cells |
human neonatal kidney cells |
|
HP |
High Potency |
|
HPAA |
Health Policy and Administration |
|
HPFB |
Health Products and Food Branch (Canada) |
|
HPK |
Human PharmacoKinetic |
|
HPO |
High Performance Organization |
|
HPUS |
Homeopathic Pharmacopeia of the United States |
|
HQ |
Headquarters (HDQ Preferred) |
|
HQO |
Home Quarantine Order |
|
HRG |
Health Research Group |
|
HRRC |
Human Research Review Committee |
|
HRSA |
U.S. Health Resources and Services Administration |
|
HSA |
Health Services Administration |
|
HSBT |
Heat Stable Bacterial Toxins |
|
HSIN |
Homeland Security Information Network |
|
HSOC |
Homeland Security Operations Center |
|
HSPD |
Homeland Security Presidential Directive |
|
HSs |
hemophilia surveillance system |
|
HSUS |
Humane Society of the United States |
|
HTLV |
human T-lymphotropic viruse |
|
HTLV-III |
human lymphotropic virus, type III (AIDS agent, HIV) |
|
HTM |
Health Technical Memorandum |
|
HTML |
Hyper-Text Markup Language |
|
HTN |
Hypertension |
|
HTRB (CBER) |
Human Tissue and Reproduction Branch (CBER) |
|
HTTP |
Hypertext Transfer Protocol |
|
HVAC |
Heating, Ventilating, And Air Conditioning |
|
Hx |
Medical History |
|
I & D |
incision and drainage |
|
I & O |
intake and output |
|
I&D |
Incision and Drainage |
|
I&O |
Intake & Output |
|
IA |
Import Administration (United States Department of Commerce) |
|
IAB (CDRH) |
Information and Analysis Branch (CDRH) |
|
IAB (ORA) |
Infrastructure Applications Branch (ORA) |
|
IACUC |
Institutional Animal Care and Use Committee |
|
IAG |
Inter-Agency Agreement |
|
IAL |
Informal Action Level |
|
IAMFES |
International Association of Milk, Food and Environmental Sanitarians |
|
IAN |
International Approved Names for pharmacopoeial substances |
|
IARC |
International Agency for Research on Cancer |
|
IAS (OC) |
International Agreements Staff (OC) |
|
IAST (CFSAN) |
International Activities Staff (CFSAN) |
|
IATA |
International Air Transport Association |
|
IAVG |
Interagency Vaccine Group |
|
IAW |
In Accordance With |
|
IB |
Investigator's Brochure |
|
IB (CFSAN) |
Immunobiology Branch (CFSAN) |
|
IB (ORA) |
International Branch (ORA) |
|
IBB (CFSAN) |
Instrumentation and Biophysics Branch (CFSAN) |
|
IBD |
International Birth Date |
|
IBE |
individual bioequivalence |
|
IBP |
Indian Black Pepper certificate |
|
IBR (CFSAN) |
Import Branch (CFSAN) |
|
ICAM |
International Cooperative Agreements Manual |
|
ICAO |
International Civil Aviation Organization |
|
ICB (CDRH) |
Inspection and Compliance Branch (CDRH) |
|
ICB (CFSAN) |
Implementation and Compliance Branch (CFSAN) |
|
ICCBBA |
International Council for Commonality in Blood Banking Automation, Inc. |
|
ICCR |
International Cooperation on Cosmetics Regulation |
|
ICCVAM |
Inter-agency Coordinating Committee on Validation of Alternative Methods |
|
ICD |
Informed Consent Document |
|
ICD-9-CM |
International Classification of Diseases, Ninth Revision, Clinical Modification |
|
ICDR |
Interagency Committee on Disability Research |
|
ICE |
Immigration and Customs Enforcement (Department of Homeland Security) |
|
ICF |
Informed Consent Form |
|
ICH |
International Conference on Harmonization (of Technical Requirements for Registration of Pharmaceuticals for Human Use) |
|
ICIB (CDRH) |
Intraocular and Corneal Implants Branch (CDRH) |
|
ICL |
idiopathic CD4 T-lymphocytopenia |
|
ICLAS |
International Council for Laboratory Animal Science |
|
ICMJE |
International Committee of Medical Journal Editors |
|
ICPEMC |
International Commission for Protection against Environmental Mutagens and Carcinogens |
|
ICRP |
International Commission on Radiological Protection |
|
ICRU |
International Commission on Radiation Units and Measurements |
|
ICS |
Incident command system |
|
ICSR |
Individual Case Safety Report |
|
ICU |
Intensive Care Unit |
|
IDBD |
Infectious Disease Biomarker Database |
|
IDBR |
Infectious Disease Board Review |
|
IDC |
Information and Data Committee |
|
IDDM |
insulin-dependent diabetes mellitus |
|
IDE (CDRH) |
Investigational Device Exemptions Sections (CDRH) |
|
IDF |
Immune Deficiency Foundation |
|
IDHL |
Inherently Dangerous to Human Life |
|
IDIQ |
indefinite-delivery, indefinite-quantity [contracts] |
|
IDL |
International Date Line |
|
IDM |
Informational Disclosure Manual |
|
IDP |
Individual Development Plan |
|
IDR |
Idiosyncratic Drug Reaction |
|
IEC |
Independent Ethics Committee |
|
IEE |
Intervention Effect Estimate |
|
IEEE |
Institute of Electrical and Electronics Engineers |
|
IFAD |
International Food Additives Database |
|
IFE |
Import for Export |
|
IFIC |
International Food Information Council |
|
IFIP |
International Federation For Information Processing |
|
IFMFS (CFSAN) |
Infant Formula and Medical Foods Staff (CFSAN) |
|
IFT |
Institute of Food Technologists |
|
IFU |
Instructions For Use |
|
IFWG |
Interagency Food Working Group |
|
IG |
Inspector General (HHS) |
|
IgA |
Immunoglobin A |
|
IgD |
Immunoglobin D |
|
IGIV |
Immune Globulin Intravenous |
|
IgM |
VCA)-immunoglobin M |
|
IHS |
Indian Health Service |
|
IHSP |
influenza Hospitalization Surveillance Project |
|
IIC |
Inspector-In-Charge |
|
IIFAR |
Incurably Ill for Animal Research |
|
IIG |
Inactive Ingredient Guide |
|
IIMB (CDRH) |
IT Infrastructure Management Branch (CDRH) |
|
IIMG |
Interagency Incident Management Group |
|
IIS |
Internet Information Services |
|
ILAR |
Institute For Laboratory Animal Research |
|
ILInet |
Influenza-like Illness Surveillance Network |
|
IMB |
Irish Medicines Board |
|
IMB (CDER) |
Interface Management Branch (CDER) |
|
IMB (CDRH) |
Information Management Branch (CDRH) |
|
IMC |
Information Management Consultants, Inc. |
|
IMCC |
Information Management Coordinating Committee |
|
IMDA |
Irish Medical Device Association |
|
IMDB (CDRH) |
Immunology and Molecular Diagnostics Devices Branch (CDRH) |
|
IMLS |
Institute of Museum and Library Services |
|
IMO |
International Maritime Organization |
|
IMP |
Investigational Medicinal Product |
|
IMPD |
Investigational Medicinal Product Dossier (EU) |
|
IMS |
Information Management System (LTPP) |
|
IMS (CDRH) |
Issues Management Staff (CDRH) |
|
IMTS |
Industry Meeting Tracking System |
|
INA |
Investigational New Animal drug number |
|
INAD |
Investigational New Animal Drug |
|
INADA |
Investigational New Animal Drug Application |
|
INCI |
International Nomenclature of Cosmetic Ingredients |
|
IND |
Investigational New Drug |
|
INDA |
Investigational New Drug Application |
|
INDC |
Investigational New Drug Committee |
|
INDE |
Investigational New Drug Exemption |
|
INFARMED |
Instituto Nactional da FARMaciae e do MEDicamento (Portugal) |
|
INN |
International Non-Proprietary Name |
|
INNS |
International Neural Network Society |
|
INRO |
Intramural NIAID Research Opportunities (National Institute of Allergy and Infectious Diseases) |
|
INS |
Incident of National Significance |
|
INV SAMPLE |
INVestigational Sample |
|
IO |
Immediate Office |
|
IOB |
International Operations Branch (ORA) |
|
IOM |
Investigation Operations Manual |
|
IOTF |
Interagency Oncology Task Force |
|
IPC |
In-Process Control |
|
IPCB (CDER) |
Investigations and Preapproval Compliance Branch (CDER) |
|
IPCS |
International Programme on Chemical Safety |
|
IPEC |
International Pharmaceutical Excipients Council |
|
IPM |
Import Program Manager |
|
IPO |
Initial Public Offering |
|
IPOAB |
Information Processing and Office Automation Branch |
|
IPOAB (CDRH) |
Information Processing and Office Automation Branch (CDRH) |
|
IPPIA |
International Plasma Products Industry Association |
|
IPRMS (OC) |
International Planning and Resource Management Staff (OC) |
|
IPRO |
Independent Pharmaceutical Research Organization |
|
IPU |
Irish Pharmaceutical Union |
|
IPV |
Inactivated Polio Vaccine |
|
IQ |
Installation Qualification |
|
IQA |
Institute of Quality Assurance (UK) |
|
IQMP |
Integrated Quality Management Plan |
|
IRA |
Immediate Response Authority |
|
IRDM |
Insulin Resistant Diabetes Mellitus |
|
IREAS (CDRH) |
International Relations and External Affairs Staff (CDRH) |
|
IRIS |
International Regulatory Issues Staff |
|
IRM |
Information Resources Management |
|
IRMC |
Information Resources Management College |
|
IRPB |
International Research and Programs Branch |
|
IRS (OC) |
International Relations Staff (OC) |
|
ISA |
Information Systems Architecture |
|
ISAC |
Information Sharing and Analysis Center |
|
ISASS (OC) |
International Scientific Activities and Standards Staff (OC) |
|
ISB (CDRH) |
Inspection Support Branch (CDRH) |
|
ISBT |
International Society of Blood Transfusion |
|
ISBT 128 |
International Society of Blood Transfusion standard for blood, tissue, and organ identification |
|
ISDN |
Integrated Services Digital Network |
|
ISE |
Integrated Summary of Efficiency |
|
ISIS |
import support and information system |
|
ISMP |
Institute for Safe Medication Practices |
|
ISP |
Internet Service Provider |
|
ISR |
Individual safety report |
|
ISS |
Integrated Summary of Safety |
|
ISS/ISE |
Integrated Summary of Safety / Integrated Summary of Effectiveness |
|
ISSO |
Information Systems Security Officer |
|
IT |
Information Technology |
|
ITA |
International Trade Administration |
|
ITACS |
Import Trade Auxiliary Communication System |
|
ITATMT (OC) |
IT Asset Tracking and Management Team (OC) |
|
ITB (CFSAN) |
Immunotoxicology Branch (CFSAN) |
|
ITC |
International Trade Commission |
|
ITCB (OC) |
Information Technology Contracts Branch (OC) |
|
ITCC |
Information Technology Coordinating Committee |
|
ITDS |
International Trade Data System |
|
ITF |
Inspection Task Force (CBER) |
|
ITGS (OC) |
IT Governance Staff (OC) |
|
ITIC |
Information Technology Implementation Committee (CBER) |
|
ITIPS |
Information Technology Investment Portfolio System |
|
ITS |
Information Technology Staff |
|
ITS (CBER) |
Information Technology Staff (CBER) |
|
ITSO |
Information Technology Services Officer |
|
ITT |
Intent to Treat |
|
ITTT |
Information Technology Training Team |
|
IUO |
investigation use only |
|
IUPAC |
International Union of Pure and Applied Chemistry |
|
IV |
Intravenous |
|
IV & V |
independent verification and validation |
|
IV&V |
independent verification and validation |
|
IVD |
In-Vitro Diagnostics |
|
IVDs |
in-vitro diagnostic devices |
|
IVF |
in vitro fertilization; |
|
IVMD |
In-Vitro Medical Device |
|
IVP |
Intravenous Pyelogram |
|
IVTB (CFSAN) |
In Vitro Toxicology Branch (CFSAN) |
|
J-ART |
Japanese Adverse Reaction Terminology |
|
J/D |
Judgment for the Defendant |
|
JAD |
Joint Application Development |
|
jan |
Japanese Adopted Names |
|
JBIG |
Joint Bi-level Image experts Group |
|
JCAHO |
Joint Commission on Accreditation of Health Care Organizations |
|
JECFA |
Joint (FAO/WHO) Expert Committee on Food Additives |
|
JFHQ |
Joint Force Headquarters |
|
JFTR |
Joint Federal Travel Regulations |
|
JIC |
Joint Information Center |
|
JIFSAN |
Joint Institute for Food Safety and Applied Nutrition |
|
JIFSAN (CFSAN) |
JIFSAN Liaison Staff (CFSAN) |
|
JINAD |
Generic Investigational New Animal Drug File |
|
JLCS (OC) |
Jefferson Laboratory Complex Staff (OC) |
|
JMO |
Japanese Maintenance Organization |
|
JMPR |
Joint FAO-WHO Meeting of Pesticide Residues |
|
JPEG |
Joint Photographic Experts Group (24-bit image storage format) |
|
JPMA |
Japan Pharmaceutical Manufacturers Association |
|
JRIES |
Joint Regional Information Exchange System |
|
JTF |
Joint Task Force |
|
JTR |
Joint Travel Regulations |
|
kcal |
kilocalories |
|
kg |
Kilogram |
|
KMT (OC) |
Knowledge Management Staff (OC) |
|
KOS |
Knowledge Organization System |
|
KPS |
Karnofsky Performance Status scale |
|
KS |
Kaposi's Sarcoma |
|
L & D |
labor and delivery |
|
LACF |
Low-Acid Canned Food |
|
LAF |
Laminar Air Flow |
|
LAN |
Local Area Network |
|
Langual |
Langua Alimentaria (Language of Foods) |
|
LAR |
Licensing Action Recommendation |
|
LARD |
Licensing Action Recommendation Document |
|
LARM |
Licensing Action Recommendation Memorandum |
|
LASA |
Linear Analog Self-Assessment measure |
|
LASER |
Light Amplification By Stimulated Emission Of Radiation (cf. Maser) |
|
LASIK |
Laser ASisted In-situ Keratomileusis |
|
LATS |
License Application Tracking System |
|
LBL |
Ernest Orlando Lawrence Berkeley National Laboratory |
|
LBP |
Laboratory of Bacterial Polysaccharides |
|
LBP (CBER) |
Laboratory of Bacterial Polysaccharides (CBER) |
|
LBPUA (CBER) |
Laboratory of Bacterial, Parasitic and Unconventional Agents (CBER) |
|
LBVB |
Laboratory of Biochemistry and Vascular Biology |
|
LCDC |
Laboratory Centre for Disease Control |
|
LCH |
Laboratory of Cellular Hematology |
|
LCH (CBER) |
Laboratory of Cellular Hematology (CBER) |
|
LCI |
Livestock Conservation Institute |
|
LCP |
Laboratory of Clinical Pharmacology |
|
LCP (CDER) |
Laboratory of Clinical Pharmacology (CDER) |
|
LCT |
Labeling Compliance Team |
|
LCT (CFSAN) |
Labeling Compliance Team (CFSAN) |
|
LD |
Lethal Dose |
|
LD50 |
Lethal Dose where 50% of the population dies |
|
LDPE |
Low Density Poly-Ethylene |
|
LDV (CBER) |
Laboratory of DNA Viruses (CBER) |
|
LEAA |
Law Enforcement Alliance of America |
|
LECC |
Law Enforcement Coordination Committee |
|
LERN |
Library Electronic Reference Network |
|
LES |
Leave and Earnings Statement |
|
LESTD (CBER) |
Laboratory of Enteric and Sexually Transmitted Diseases (CBER) |
|
LF |
Low Frequency |
|
LF1 |
Low-value Food or Food-related products, level 1 (less than $200) |
|
LF2 |
Low-value Food or Food-related products, level 2 (between $200 and $500) |
|
LF3 |
Low-value Foor or Food-related products, level 3 (between $500 and $1000) |
|
LGA |
large for gestational age |
|
LH (CBER) |
Laboratory of Hemostasis (CBER) |
|
LHREA (CBER) |
Laboratory of Hepatitis and Related Emerging Agents (CBER) |
|
LHV |
Laboratory of Hepatitis Viruses |
|
LHV (CBER) |
Laboratory of Hepatitis Viruses (CBER) |
|
LI |
Learned Intermediary |
|
LIB (CBER) |
Laboratory of Immunobiochemistry (CBER) |
|
LIMS |
Laboratory Information Management System |
|
LIR |
Laboratory of Immunoregulation |
|
LIR (CBER) |
Laboratory of Immunoregulation (CBER) |
|
LM |
Listeria monocytogenes |
|
LMD (CBER) |
Laboratory of Method Development (CBER) |
|
LMDCI (CBER) |
Laboratory of Mycobacterial Diseases and Cellular Immunology (CBER) |
|
LMDQC (CBER) |
Laboratory of Methods Development and Quality Control (CBER) |
|
LMO |
Living Modified Organism |
|
LMS |
LABORATORY MANAGEMENT SYSTEM |
|
LMV (CBER) |
Laboratory of Molecular Virology (CBER) |
|
LNC |
Labeling and Nomenclature Committee |
|
LNE |
Laboratoire National de Metrologie et d'Essias (National Laboratory of Metrology and Essays) |
|
LOA |
Letter Of Agreement |
|
LOAEL |
Lowest Observed Adverse Effect Level |
|
LOB (ORA) |
Laboratory Operations Branch (ORA) |
|
LOC |
Level Of Concern |
|
LOCF |
Last Observation Carried Forward |
|
LOD |
Limit Of Detection |
|
LOEL |
Lowest Observed Effect Level |
|
LOINC |
Logical Observation Identifier Name Code |
|
LOQ |
Limit Of Quantification |
|
LOV |
List Of Values |
|
LPB (OC) |
Leasing and Policy Branch (OC) |
|
LPD (CBER) |
Laboratory of Plasma Derivatives (CBER) |
|
LPET (CFSAN) |
Laboratory Proficiency and Evaluation Team (CFSAN) |
|
LPRVD (CBER) |
Laboratory of Pediatric and Respiratory Viral Diseases (CBER) |
|
LPT (CFSAN) |
Liaison and Policy Team (CFSAN) |
|
LR (CBER) |
Laboratory of Retroviruses (CBER) |
|
LR1 |
Low-value non-prescription Radiation-emitting products, level 1 (less than $200) |
|
LR2 |
Low-value non-prescription Radiation-emitting products, level 2 (between $200 and $1000) |
|
LRA |
Local Registration Authority |
|
LRB (CDER) |
Labeling Review Branch (CDER) |
|
LRC |
Lipid Research Clinic |
|
LRI |
Lower Respiratory Infection |
|
LRIS |
Lot Release Imaging System |
|
LRIT (CFSAN) |
Labeling Regulations Implementation Team (CFSAN) |
|
LRN |
Laboratory Response Network |
|
LRP |
Low Regulatory Priority |
|
LRPDB (CDRH) |
Labeling Research and Policy Development Branch (CDRH) |
|
LRS |
Lot Release System |
|
LRSP (CBER) |
Laboratory of Respiratory and Special Pathogens (CBER) |
|
LS |
Labelling Standard |
|
LS (CDRH) |
Library Staff (CDRH) |
|
LS/LS |
Life Supporting/Life Sustaining |
|
LSD |
Lysergic Acid Diethylamide |
|
LSHLC |
Lipid-Soluble Heat-Labile Chemical |
|
LSHSC |
Lipid-Soluble Heat-Stable Chemical |
|
LST |
LiSTing number of a device |
|
LTSS |
Long-Term Services and Supports |
|
LUACRG |
Lung and Upper Aerodigestive Cancer Research Group |
|
LVBD (CBER) |
Laboratory of Vector-Borne Diseases (CBER) |
|
LVCH |
Local VouCHer |
|
LVP |
Large-Volume Parenteral |
|
LWC |
Lead Wire or patient Cable |
|
M&IE |
Meals and Incidental Expenses |
|
M2 |
ICH M2 Expert Working Group (EWG) [electronic standards for transmission of regulatory information] |
|
M2 EWG |
ICH M2 Expert Working Group |
|
M204 |
Model 204 DataBase Management System |
|
M4 |
ICH M4 Expert Working Group (EWG) [focusing on Common Technical Documents for sections of the NDA] |
|
M4 EWG |
ICH M4 Expert Working Group |
|
MA |
Marketing Authorization |
|
MAB (CDER) |
Management Analysis Branch (CDER) |
|
MAB (CFSAN) |
Methods Application Branch (CFSAN) |
|
MAC |
Mental Adjustment to Cancer Scale |
|
MACMIS |
Marketing, Advertising and Communication Management Information System |
|
MacPAC |
Medicaid and CHIP Payment and Access Commission |
|
MACS |
Manufacturers Assistance and Communications Staff |
|
MACS (CBER) |
Manufacturers Assistance and Communications Staff (CBER) |
|
MAD |
Multiple Ascending Dose |
|
MAH |
Marketing Authorization Holder |
|
MAPCB (CDER) |
Manufacturing Assessment & Pre-Approval Compliance Branch (CDER) |
|
MAPP |
Manual of Policy and Procedures |
|
MARCS |
Mission Accomplishment and Regulatory Compliance Services System (ORA) |
|
MARS |
Mobile Automated Regulatory Services (ORA) |
|
MAS cell |
manipulated autologous structural cell |
|
MASC |
Manipulated Autologous Structural Cell |
|
MAT |
Modular Antigen Transporter |
|
MATS |
Management Assignment Tracking System |
|
MATTB |
Manufacturers Assistance and Technical Training Branch |
|
MATTB (CBER) |
Manufacturers Assistance and Technical Training Branch (CBER) |
|
MAV |
maximum allowable variation |
|
MB (CFSAN) |
Microanalytical Evaluations Branch of the Center for Food Safety and Applied Nutrition |
|
MBC |
Minimum Bactericidal Concentration |
|
mbes |
Medicaid Budget and Expenditure System |
|
MCA |
Medicines Control Agency (part of MHRA) |
|
MCAFT |
Modified Canadian Aerobic Fitness Test |
|
MCM |
Medical Countermeasures |
|
MCMi |
Medical Countermeasures Initiative |
|
MCO |
Managed Care Organization |
|
MDB (CFSAN) |
Methods Development Branch (CFSAN) |
|
MDCN |
Medicare Data Communication Network |
|
MDDRP |
Medical Device Dispute Resolution Panel |
|
MDI |
Metered-Dose Inhaler |
|
MDII |
Medical Device Innovation Initiative |
|
MDL |
MoDeL number |
|
MDMA |
Medical Device Manufacturers Association |
|
MDP |
Medical Devices Program |
|
MDR |
Medical Device Reporting |
|
MDUFA |
Medical Device User Fee Amendments of 2007 |
|
MDUFMA |
Medical Device User Fee and Modernization Act of 2002 |
|
MDUFSA |
Medical Device User Fee Stabilization Act of 2005 |
|
MDV |
Medical Device Vigilance |
|
ME |
Medical Examiner |
|
MedDRA |
Medical Dictionary for Regulatory Activities (new global standard medical terminology designed to supersede other terminolgies used in the medical product development process, including COSTART, ICD9 and others) |
|
MEDEC |
Medical Devices Canada |
|
MedPAC |
Medicare Payment Advisory Commission |
|
MEDSA |
Medicine Equity and Drug Safety Act of 2000 |
|
MedSuN |
Medical Product Safety Network |
|
MEFA |
Foreningen Af MEdicinfabrikanter |
|
MEG |
Magnetoencephalography |
|
MEMO |
Medicines Evaluation and Monitoring Organization |
|
MEO |
Most Efficient Organization (Navy) |
|
MERCOSUR |
MERcado COmún del SUR (Southern Common Market) |
|
MERP |
Medication Error Reporting and Prevention |
|
MERS-TM |
Medical Event Reporting System - Transfusion Medicine |
|
MF |
Master File |
|
MFA |
Medicated Feed Application number |
|
MFC |
Model Food Code |
|
MFCU |
Medicaid Fraud Control Unit |
|
MFR |
ManuFactureR |
|
MFRPS |
Manufactured Food Regulatory Program Standards |
|
MGB |
Molecular Genetics Branch |
|
MGB (CFSAN) |
Molecular Genetics Branch (CFSAN) |
|
MGSS |
Multi-Generation Support System |
|
MHBG |
Mental Health Services Block Grant |
|
MHPF |
Minority Health Professionals Foundation |
|
MHSB |
Microbial Hazards Science Branch |
|
MHSB (CFSAN) |
Microbial Hazards Science Branch (CFSAN) |
|
MHW |
Ministry of Health and Welfare (Japan) |
|
MI |
Myocardial Infarction |
|
MIC |
Minimum Inhibitory Concentration |
|
MID |
Manufacturer IDentifier |
|
mIg |
Medicaid Infrastructure Grant |
|
MIP |
Management Improvement Plan |
|
MIRA |
Medicare Innovation Responsiveness Act of 2003 |
|
MIS (OC) |
Management Initiatives Staff (OC) |
|
MITA |
Medicaid Information Technology Architecture |
|
MIWG |
Mentoring Implementation Working Group |
|
MJ |
Major Amendment |
|
ML |
Manufacturer's License |
|
MLD |
Minimum Lethal Dose |
|
MLTC |
Managed Long-Term Care |
|
MMA |
Medicare Prescription Drug, Improvement and Modernization Act of 2003 |
|
MMAB (CFSAN) |
Microbiological Methods Application Branch of the Center for Food Safety and Applied Nutrition |
|
MMDB |
Microbial Methods Development Branch |
|
MMDB (CFSAN) |
Microbial Methods Development Branch (CFSAN) |
|
MMR |
measles, mumps, and rubella |
|
MMRB |
Microbiological Methods Research Branch |
|
MMRB (CFSAN) |
Microbiological Methods Research Branch (CFSAN) |
|
MMSB |
Molecular Methods and Subtyping Branch |
|
MMSB (CFSAN) |
Molecular Methods and Subtyping Branch (CFSAN) |
|
MMWR |
Morbidity and Mortality Weekly Report |
|
MNVP |
Medically Necessary Veterinary Product |
|
MOC |
Management and Operations Council |
|
MOD |
Miscellaneous Obligation Document |
|
MOD 1 |
Module One laboratory facility |
|
MOD 2 |
Module Two laboratory facility |
|
MON |
Memorandum of Need |
|
MOU |
Memorandum of Understanding (an MOU between Food & Drug Administratin and a regulatory agency in another country allows mutual recognition of inspections) |
|
MPAB |
Management Programs and Analysis Branch |
|
MPAB (OC) |
Management Programs and Analysis Branch (OC) |
|
MPCC |
Medical Policy Coordinating Committee |
|
MPEG |
Moving Pictures Experts Group |
|
MPN |
Metro Park North |
|
MPQA |
Medical Products Quality Assurance |
|
MQSA |
Mammography Quality Standards Act of 1992 |
|
MRB |
Material Review Board |
|
MRB (CFSAN) |
Methods Research Branch (Center for Food Safety and Applied Nutrition) |
|
MRD |
Multiple Rising Dose |
|
MRE |
Meal, Ready-To-Eat |
|
MRFG |
Mutual Recognition Facilitating Group |
|
MRI |
Magnetic Resonance Imaging |
|
MRL |
Maximum Residue Limit |
|
mrp |
material requirements planning |
|
MRRA |
Microbial Research and Risk Assessment Staff |
|
MRRA (CFSAN) |
Microbial Research and Risk Assessment Staff (CFSAN) |
|
MRTP |
Modified Risk Tobacco Products |
|
MSAB |
Manufacturing and Storage Adulteration Branch |
|
MSAB (CFSAN) |
Manufacturing and Storage Adulteration Branch (CFSAN) |
|
MSDS |
Material Safety Data Sheets |
|
MSI |
Magnetic Source Imaging |
|
MSQA |
Mammography Quality Standards Act of 1992 |
|
MSS (CDRH) |
Management Support Staff (Center for Devices and Radiological Health) |
|
MSS (CVM) |
Management Support Staff (CDRH) |
|
MSSO |
Maintenance and Support Services Organization |
|
MSTD |
Materials Science and Technology Department |
|
MSU |
Medical Statistics Unit |
|
MT |
Medical Team |
|
MT (CFSAN) |
Medical Team (CFSAN) |
|
MTBF |
Mean Time Between Failures |
|
MTCT |
mother-to-child transmission |
|
MTD |
Maximum Tolerated Dose (that does not produce unacceptable toxicity) |
|
MTOS |
Muirkirk Technical Operations Staff (Laurel, Maryland) |
|
MTOS (CFSAN) |
Muirkirk Technical Operations Staff (CFSAN) |
|
MUMS |
Minor Use and Minor Species Animal Health Act of 2004 |
|
MUMS (CVM) |
Office of Minor Use and Minor Species (CVM) |
|
MUMS Act |
Minor Use and Minor Species Animal Health Act of 2004 |
|
MVB |
Molecular Virology Branch |
|
MVB (CFSAN) |
Molecular Virology Branch (CFSAN) |
|
MVT |
Molecular Virology Team |
|
MVT (CFSAN) |
Molecular Virology Team (CFSAN) |
|
MWG |
Milk Working Group |
|
n.b. |
nota bene (note well) |
|
N/A |
Not Applicable |
|
NA |
Not Approvable |
|
NAA |
National Aquaculture Association |
|
NABR |
National Association for Biomedical Research |
|
NACCHO |
National Association of County and City Health Officials |
|
NACDS |
National Association of Chain Drug Stores |
|
NACHO |
National Association of County Health Officials |
|
NACMCF |
National Advisory Committee on Microbiological Criteria for Foods |
|
NAD |
NED Animal Drug number |
|
NADE |
New Animal Drug Evaluation |
|
NAET |
Nutrition Assessment and Evaluation Team |
|
NAET (CFSAN) |
Nutrition Assessment and Evaluation Team (CFSAN) |
|
NAF |
Notice of Adverse Findings |
|
NAFTA |
North American Free Trade Agreement |
|
NAGC |
National Association of Government Communicators |
|
NAHC |
National Advisory Health Council |
|
NAI |
No Action Indicated (Most Favorable Food & Drug Administration Post-inspection Classification) |
|
NAION |
non-arteritic anterior ischemic optic neuropathy |
|
NAL |
National Agricultural Library |
|
NALBOH |
National Association of Local Boards of Health |
|
NAM |
National Agency for Medicines |
|
NARA |
United States National Archives And Records Administration |
|
NARB |
National Advertising Review Board |
|
NARMS |
National Antimicrobial Resistance Monitoring System |
|
NASA |
National Aeronautics and Space Administration (US) |
|
NASAR |
National Association of Search and Rescue |
|
NASDA |
National Association of State Departments of Agriculture |
|
NASS |
National Agricultural Statistics Service |
|
NAT |
Nucleic Acid-based Tests |
|
NATAG |
North American Technical Advisory Group |
|
NBAC |
National Bioethics Advisory Commission (replaced By PCBE; Archived At GU) |
|
NBCS |
National Biomedical Computer System |
|
NBDRC |
National Blood Data Resource Center |
|
NBII |
National Biological Information Infrastructure |
|
NBS |
National Bureau of Standards (US) |
|
NC |
Non-Clinical |
|
NCAB |
National Cancer Advisory Board |
|
NCBA |
National Cattlemen's Beef Association |
|
NCBDDD |
National Center on Birth Defects and Developmental Disabilities |
|
NCBI |
National Center for Biotechnology Information |
|
NCC |
National Coordinating Committee |
|
NCC MERP |
National Coordinating Council for Medication Error Reporting and Prevention |
|
NCCAM |
National Center for Complementary and Alternative Medicine |
|
NCCDPHP |
National Center for Chronic Disease Prevention and Health Promotion |
|
NCCLS |
National Committee for Clinical Laboratory Standards |
|
NCDC |
National Centre for Disease Control, India |
|
NCDCP |
National Council on Prescription Drug Programs |
|
NCE |
New Chemical Entity |
|
NCEH |
National Center for Environmental Health |
|
NCER |
Non-Conformance Escalation Report |
|
NCFST |
National Center for Food Safety & Technology |
|
NCHGR |
National Center for Human Genome Research (NIH) |
|
NCHM |
National Center for Health Marketing |
|
NCHS |
National Center for Health Statistics standards |
|
NCHSTP |
National Center for HIV, STD, & TB Prevention |
|
NCI |
National Cancer Institute, USA |
|
NCID |
National Center for Infectious Diseases (CDC) |
|
NCIMS |
National Conference on Interstate Milk Shipments |
|
NCIPC |
National Center for Injury Prevention and Control (CDC) |
|
NCL |
National Consumers League |
|
NCMHD |
National Center on Minority Health and Health Disparities (NIH) |
|
NCNR |
National Center for Nursing Research (NIH) |
|
NCP |
Non-Conforming Product |
|
NCPDP |
National Council for Prescription Drug Programs |
|
NCPHI |
National Center for Public Health Informatics (CDC) |
|
NCR |
Non-Conformance Report |
|
NCRM |
National Comorbidity Survey Replication |
|
NCRP |
National Council on Radiation Protection and Measurements |
|
NCRR |
National Center for Research Resources (NIH) |
|
NCSES |
National Center for Science and Engineering Statistics (NSF) |
|
NCTR |
National Center for Toxicological Research |
|
NCVHS |
National Committee on Vital and Health Statistics |
|
NCVIA |
National Childhood Vaccine Injury Act of 1986 |
|
NCWM |
National Conference on Weights and Measures |
|
NDAB |
National Drugs Advisory Board |
|
NDAC |
Nonprescription Drug Advisory Committee |
|
NDC |
National Drug Code |
|
NDCR |
New Drug Comparison Rating |
|
NDE |
New Drug Evaluation |
|
NDE/MIS |
New Drug Evaluation Management Information System |
|
NDF-RT |
National Drug File Reference Terminology |
|
NDI |
National Death Index (CDC) |
|
NDIRS |
New Dietary Ingredients Review Staff |
|
NDIRS (CFSAN) |
New Dietary Ingredients Review Staff (CFSAN) |
|
NDMA |
Nonprescription Drug Manufacturers Association (now CHPA) |
|
NDMS (CDER) |
New Drug Microbiology Staff (CDER) |
|
NDRMMP |
National Drug Residue Milk Monitoring Program |
|
NDTI |
National Disease and Therapeutic Index |
|
NE-FO (ORA) |
Regional Field Office, Northeast Region |
|
NEC |
not elsewhere classified |
|
NED |
NIH (National Institutes of Health) Enterprise Directory |
|
NEDSS |
National Electronic Disease Surveillance System |
|
NEEP |
National Exercise and Evaluation Program |
|
NEFARMA |
NEederlandse FARMAceutische Industrie (NEtherland Association of the Research-oriented PHARMAceutical Industry) |
|
NEFLE |
National Exchange for Food Labeling Education |
|
NEHA |
National Environmental Health Association |
|
NEI |
National Eye Institute (National Institutes of Health) |
|
NEMA |
National Emergency Management Association |
|
NEP |
National Exercise Program |
|
NEPA |
National Environmental Policy Act |
|
NETBEUI |
NETBIOS Extended User Interface |
|
NEXT |
Nationwide Evaluation of X-ray Trends (CDRH) |
|
NF |
National Formulary |
|
NFPA |
National Food Processors Association |
|
NFSS |
National Food Safety System |
|
NFT |
Notification of Foreign Travel |
|
NGA |
National Geospatial-Intelligence Agency (formerly National Imagery and Mapping Agency; US government) |
|
NGB |
National Guard Bureal |
|
NGC |
National Guideline Clearinghouse (DHHS) |
|
NGFA |
National Grain and Feed Association |
|
NGO |
Non-governmental organization. (Red Cross/Crescent, Doctors without Borders, etc.) |
|
NHANES |
National Health and Nutrition Examination Survey |
|
NHC |
United States National Hurricane Center |
|
NHE |
National Health Expenditures |
|
NHF |
National Hemophilia Foundation |
|
NHIC |
National Health Information Center |
|
NHIN |
Nationwide Health Information Network |
|
NHIS |
National Institute of Hygienic Sciences |
|
NHLBI |
National Heart, Lung, and Blood Institute |
|
NHRIC |
national health related items code (CDRH) |
|
NHW |
National Health and Welfare Department (Canada's equivalent of DHHS) |
|
NIA |
National Institute on Aging |
|
NIAAA |
National Institute on Alcohol Abuse and Alcoholism |
|
NIAMS |
National Institute of Arthritis and Musculoskeletal and Skin Diseases |
|
NIBIB |
National Institute of Biomedical Imaging and Bioengineering |
|
NICCL |
National Incident Communications Conference Line |
|
NICE |
National Institute for Health and Clinical Excellence |
|
NICHD |
National Institute of Child Health and Human Development |
|
NIDA |
National Institute on Drug Abuse (National Institutes of Health) |
|
NIDCR |
National Institute of Dental and Craniofacial Research |
|
NIDDK |
National Institute of Diabetes and Digestive and Kidney Diseases |
|
NIDPOE |
Notice of Initiation of Disqualification Proceeding and Opportunity to Explain |
|
NIDR |
National Institute of Dental Research (see NIDCR) |
|
NIDRR |
National Institute on Disability and Rehabilitation Research |
|
NIEHS |
National Institute of Environmental Health Sciences (National Institutes of Health) |
|
NIFC |
National Interagency Fire Center |
|
NIGMS |
National Institute Of General Medical Sciences (NIH) |
|
NIM |
No Inspection Made |
|
NIMH |
National Institute of Mental Health (NIH) |
|
NIMS |
National Incident Management System |
|
NINDS |
National Institute of Neurological Disorders and Stroke |
|
NINR |
National Institute of Nursing Research |
|
NIOSH |
National Institute for Occupational Safety and Health (CDC) |
|
NIP |
National Immunization Program (CDC) |
|
NIPP |
National Infrastructure Protection Plan |
|
NIS |
National Inpatient Sample |
|
NISAC |
National Infrastructure Simulation and Analysis Center (Department of Homeland Security) |
|
NIST |
National Institute of Standards and Technology |
|
NKCA |
Natural Killer cell Cytotoxic Activity |
|
NLEA |
Nutrition Labeling and Education Act of 1990 |
|
NLEM |
National List of Essential Medicines |
|
NLM |
National Library of Medicine (NIH) |
|
NLN |
Nordiska LäkemedelsNämnden (Nordic Council on Medicines) |
|
NLRC |
Nicholson Lane Research Center |
|
NLT |
Not Less Than |
|
NMA |
National Medical Association |
|
NMDP |
National Marrow Donor Program |
|
NME |
New Molecular Entity |
|
NMFS |
National Marine Fisheries Services |
|
NMI |
Non-Medicinal Ingredient |
|
NMPF |
National Milk Producers Federation |
|
NMQAAC |
National Mammography Quality Assurance Advisory Committee |
|
NMR |
nuclear magnetic resonance spectroscopy |
|
NMT |
Not More Than |
|
NNC |
National Notification Center |
|
NNMC |
National Naval Medical Center |
|
NOA |
Notice Of Availability |
|
NOAA |
National Oceanographic and Atmospheric Administration (U.S.) |
|
NOAE |
no observed adverse effect |
|
NOAEL |
No Observable Adverse Effect Level |
|
NOC |
National Operations Center |
|
NOD |
Notice of Deficiency |
|
NOEL |
no observed effect level |
|
NOH |
Notice Of Hearing |
|
NOMI |
Federation of Norwegian Pharmaceutical Manufacturers |
|
NON |
Notice Of Non-Compliance |
|
NONS |
Notification of New Substance Regulations 193 (EC) |
|
NOOH |
Notice Offering an Opportunity for a Hearing |
|
NOP |
National Organic Program |
|
NOS |
Network Operating System |
|
NOSB |
National Organic Standards Board |
|
NOV |
Notice Of Violation letter |
|
NPCC |
National Poison Control Center |
|
NPCR |
National Program of Cancer Registries |
|
NPG |
National Preparedness Goal |
|
NPI |
National Provider Identifier |
|
NPPC |
National Pork Producers Council |
|
NPR |
National Performance Review (office) |
|
NPRM |
Notice of Proposed Rulemaking |
|
NPS (CFSAN) |
Nutrition Programs Staff (CFSAN) |
|
NPSB |
Nutritional Product Studies Branch |
|
NPSB (CFSAN) |
Nutritional Product Studies Branch (CFSAN) |
|
NRB |
Noninstitutional Review Board |
|
NRCC |
National Response Coordination Center |
|
NREVSS |
National Respiratory and Enteric Virus Surveillance System |
|
NRP |
National Response Plan (Department of Homeland Security) |
|
NRP-CIS |
National Response Plan Catastrophic Incident Supplement |
|
NRSP |
National Research Support Project |
|
NRTE |
Not Ready-To-Eat |
|
NS |
Not Significant |
|
NS/EP |
National Security and Emergency Preparedness |
|
NSABPB |
National Surgical Adjuvant Breast and Bowel Project |
|
NSAPB |
National Surgical Adjuvant Breast and Bowel Project |
|
NSAPE |
North American Society for Pacing and Electrophysiology |
|
NSC |
National Security Council |
|
NSE |
Not Substantially Equivalent |
|
NSIP |
National Seafood Inspection Program |
|
NSN |
National Stock Number |
|
NSR |
Non-Significant Risk |
|
NSRT |
Nutrition Science Review Team |
|
NSRT (CFSAN) |
Nutrition Science Review Team (CFSAN) |
|
NST |
National Support Team |
|
NSV-DO |
Nashville, Tennessee, District Office |
|
NSV-DO (ORA) |
Nashville (Tennessee) District Office (ORA) |
|
NSWL |
Naval Surface Weapons Laboratory (now FDA White Oak campus) |
|
NTA |
Notice to Applicants |
|
NTB |
NeuroToxicology Branch |
|
NTB (CFSAN) |
Neurotoxicology Branch (CFSAN) |
|
NTEU |
National Treasury Employees Union |
|
NTF |
National Turkey Federation |
|
ntg |
Nitroglycerin |
|
NTIA |
National Telecommunications and Information Administration |
|
NTIS |
National Technical Information Service Technology Administration |
|
NTL |
National Testing Laboratory |
|
NTP |
National Toxicology Program |
|
NUCC |
National Uniform Claim Committee |
|
NVC |
National Vaccine Commission |
|
NVCJD |
New Variant Creutzfeldt-Jakob Disease |
|
NVICP |
National Vaccine Injury Compensation Program |
|
NVLAP |
National Voluntary Laboratory Accreditation Program |
|
NVOAD |
National Volunteer Organizations Active in Disaster |
|
NVP |
National Vaccine Program |
|
NVPO |
National Vaccine Program Office |
|
NVSN |
New Vaccine Surveillance Network |
|
NVSS |
National Vital Statistics System |
|
NVTB |
Neurotoxicological and in-Vitro Toxicology Branch |
|
NVTB (CFSAN) |
Neurotoxicological and In Vitro Toxicology Branch (CFSAN) |
|
NWK-DO (ORA) |
Newark District Office (ORA) |
|
NWR |
NOAA (National Oceanic and Atmospheric Administration) Weather Radio |
|
NWS |
National Weather Service (formerly U.S. Weather Bureau) |
|
OAGS (OC) |
Officeof Acquisitions and Grants Services (OC) |
|
OAI |
Official Action Indicated (serious Food & Drug Administration post-inspection classification) |
|
OAP |
Office of Antimicrobial Products |
|
OAP (CDER) |
Office of Antimicrobial Products (CDER) |
|
OARSA |
Office of Applied Research and Safety Assessment |
|
OARSA (CFSAN) |
Office of Applied Research and Safety Assessment (CFSAN) |
|
OASDI |
Old Age Survivors Disability Insurance |
|
OASH |
Office of the Assistant Secretary for Health |
|
OAT |
Office for the Advancement of Telehealth |
|
OB |
Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) |
|
OB (CDER) |
Office of Biostatistics (CDER) |
|
OB-GYN |
Obstetrics-Gynecology |
|
OBA |
Office of Biotechnology Activities |
|
OBE |
Online Booking Engine |
|
OBES (OC) |
Office of Business Enterprise Solutions (OC) |
|
OBFP (OC) |
Office of Budget Formulation and Presentation (OC) |
|
OBI |
Office of Business Informatics |
|
OBP (CDER) |
Office of Biotechnology Products (CDER) |
|
OBPS (CDER) |
Office of Business Process Support (CDER) |
|
OBQI/M |
Outcome-Based Quality Improvement/Monitoring |
|
OBRR (CBER) |
Office of Blood Research and Review (CBER) |
|
OC |
Immediate Office of the Commissioner |
|
OC (CDER) |
Office of Compliance (CDER) |
|
OC (CDRH) |
Office of Compliance (CDRH) |
|
OC (CFSAN) |
Office of Compliance (CFSAN) |
|
OCAC (CFSAN) |
Office of Cosmetics and Colors (CFSAN) |
|
OCBQ (CBER) |
Office of Compliance and Biologics Quality (CBER) |
|
OCC (OC) |
Office of the Chief Counsel (OC) |
|
OCD (CDRH) |
Office of the Center Director (CDRH) |
|
OCD (CFSAN) |
Office of the Center Director (CFSAN) |
|
OCD (CVM) |
Office of the Center Director (CVM) |
|
OCER (CDRH) |
Office of Communication, Education and Radiological Programs (CDRH) |
|
OCI |
Office of Criminal Investigations (FDA) |
|
OCI (ORA) |
Office of Criminal Investigations (ORA) |
|
OCIO (OC) |
Office of the Chief Information Officer (OC) |
|
OCM (OC) |
Office of Crisis Management (OC) |
|
OCO (CFSAN) |
Office of Constituent Operations (CFSAN) |
|
OCOD |
Office of Communication Outreach and Development (CBER) |
|
OCP (CDER) |
Office of Clinical Pharmacology (CDER) |
|
OCP (OC) |
Office of Combination Products (OC) |
|
OCPP |
Office of Critical Path Programs |
|
OCR |
Office of Civil Rights |
|
OCS |
Office of the Chief of Staff |
|
OCTEC |
Office of Counter-Terrorism and Emergency Coordination |
|
OCTEC (CDER) |
Office of Counter-terrorism and Emergency Coordination (CDER) |
|
OCTGT |
Office of Cellular Tissue and Gene Therapies |
|
OCTGT (CBER) |
Office of Cellular, Tissue and Gene Therapies (CBER) |
|
OCTMA |
Office of Communication, Training and Manufacturers Assistance |
|
OCTMA (CBER) |
Office of Communication, Training and Manufacturers Assistance (CBER) |
|
OD |
Office of the Director |
|
OD (CBER) |
Office of the Director (CBER) |
|
OD (CDER) |
Office of the Center Director (CDER) |
|
OD (NCTR) |
Office of the Director (NCTR) |
|
ODA |
Orphan Drug Act of 1983 |
|
ODAC |
Oncologic Drugs Advisory Committee (U.S.) |
|
ODE (CDRH) |
Office of Device Evaluation (CDRH) |
|
ODE I |
Office of Drug Evaluation I (CDER) |
|
ODE II |
Office of Drug Evaluation II (CDER) |
|
ODE III |
Office of Drug Evaluation III (CDER) |
|
ODE IV (CDER) |
Office of Drug Evaluation IV (CDER) |
|
ODI |
Oswestry Disability Index |
|
ODM |
Operational Data Model |
|
ODS |
Office of Dietary Supplements |
|
ODSIR |
Office of Drug Security Integrity and Recalls |
|
OE (ORA) |
Office of Enforcement (ORA) |
|
OEEODEM (OC) |
Office of EEO and Diversity Management (OC) |
|
OEI |
Official Establishment Inventory |
|
OEL |
Occupational Exposure Level |
|
OEM |
Original Equipment Manufacturer (usually in reference to car parts) |
|
OEO (OC) |
Office of Executive Operations (OC) |
|
OEP |
Office of Emergency Preparedness (PHS) |
|
OEP (CDER) |
Office of Executive Programs (CDER) |
|
OER (OC) |
Office of External Relations (OC) |
|
OES (OC) |
Office of Executive Secretariat (OC) |
|
OEXA |
Office of External Affairs (OC) |
|
OFACS |
Office of Facilities, Acquisitions and Central Services |
|
OFAS (CFSAN) |
Office of Food Additive Safety (CFSAN) |
|
OFDCER (CFSAN) |
Office of Food Defense, Communication and Emergency Response (CFSAN) |
|
OFFAS |
Office of Field Financial and Acquisitions Services |
|
OFFAS (OC) |
Office of Field Financial and Acquisitions Services (OC) |
|
OFM (OC) |
Office of Financial Management (OC) |
|
OFPA |
Organic Foods Production Act of 1990 |
|
OFS (OC) |
Office of Financial Services (OC) |
|
OFSDO (CFSAN) |
Office of Food Safety, Defense and Outreach (CFSAN) |
|
OGC |
Office of the General Counsel (DHHS) |
|
OGD (CDER) |
Office of Generic Drugs (CDER) |
|
OGE |
Office of Government Ethics (formerly part of Office of Personnel Managment, separate executive branch in 1989) |
|
OGUD (CDRH) |
Obstetrics and Gynecology Devices Branch (CDRH) |
|
OHRMS |
Office of Human Resources and Management Services |
|
OHSC |
OCCUPATIONAL HEALTH and SAFETY CENTRE |
|
OIA |
Office of Internal Affairs |
|
OIA (OC) |
Office of Internal Affairs (OC) |
|
OIASI |
Office of International Activities and Strategic Initiatives |
|
OIASI (OC) |
Office of International Activities and Strategic Initiatives (OC) |
|
OIM |
Office of Information Management |
|
OIP |
Office of International Programs |
|
OIP (OC) |
Office of International Programs (OC) |
|
OIRA |
Office of Information & Regulatory Affairs |
|
OIT (CBER) |
Office of Information Technology (Center for Biologics Evaluation and Research) |
|
OIT (CDER) |
Office of Information Technology (Center for Drug Evaluation and Research) |
|
OIT (CDRH) |
Office of Information Technology (Center for Devices and Radiological Health) |
|
OIT (CFSAN) |
Office of Information Technology (Center for Food Safety and Applied Nutrition) |
|
OIT (CVM) |
Office of Information Technology (Center for Veterinary Medicine) |
|
OIT (NCTR) |
Office of Information Technology (National Center for Toxicological Research) |
|
OIT (OC) |
Office of Information Technology (Immediate Office of the Commissioner) |
|
OIT (ORA) |
Office of Information Technology (Office of Regulatory Affairs) |
|
OITSS (OC) |
Office of Information Technology Shared Services (Immediate Office of the Commissioner) |
|
OIVD |
Office of In-Vitro Diagnostic Device Evaluation and Safety |
|
OIVD (CDRH) |
Office of In Vitro Diagnostic Device Evaluation and Safety (CDRH) |
|
OJDB |
Orthopedic Joint Devices Branch |
|
OJDB (CDRH) |
Orthopedic Joint Devices Branch (CDRH) |
|
OLA (OC) |
Office of Legislative Affairs (Office of the Commissioner) |
|
OLE |
Object Linking and Embedding (Microsoft communication protocol) |
|
OM (CBER) |
Office of Management (Center for Biologics Evaluation and Research) |
|
OM (CDER) |
Office of Management (Center for Drug Evaluation and Research) |
|
OM (CVM) |
Office of Management (Center for Veterinary Medicine) |
|
OM (OC) |
Office of Management (Immediate Office of the Commissioner) |
|
OMB |
Office of Management and Budget (U.S.) |
|
OMB (NCTR) |
Operations and Maintenance Branch (NCTR) |
|
OMO (CDRH) |
Office of Management Operations (CDRH) |
|
OMP |
Office of Management Programs |
|
OMP (CDER) |
Office of Medical Policy (CDER) |
|
OMP (OC) |
Office of Management Programs (OC) |
|
OMRF |
Oklahoma Medical Research Foundation |
|
OMS (CFSAN) |
Office of Management Systems (CFSAN) |
|
OMS (NCTR) |
Office of Management Services (NCTR) |
|
OMT |
Oral Mucosal Transudate |
|
ONADE (CVM) |
Office of New Animal Drug Evaluation (CVM) |
|
ONC |
Office of the National Coordinator for Health Information Technology (United States Government Health and Human Services) |
|
ONCHIT |
Office of the National Coordinator for Health Information Technology |
|
OND |
Office of New Drugs |
|
OND (CDER) |
Office of New Drugs (CDER) |
|
ONDCP |
Office Of National Drug Control Policy |
|
ONDQA (CDER) |
Office of New Drug Quality Assessment (CDER) |
|
ONLDS (CFSAN) |
Office of Nutrition, Labeling and Dietary Supplements (CFSAN) |
|
ONP (CDER) |
Office of Nonprescription Products (CDER) |
|
ONPLDS (CFSAN) |
Office of Nutritional Products, Labeling and Dietary Supplements (CFSAN) |
|
OO (CFSAN) |
Office of Operations (CFSAN) |
|
OOB |
OOS out of business |
|
OODP (CDER) |
Office of Oncology Drug Products (CDER) |
|
OOP |
Order Of Predominance (in the ingredients statement) |
|
OOPD |
Office of Orphan Product Development (FDA) |
|
OOS |
Out Of Specification |
|
OP (OC) |
Office of Policy (Office of the Commissioner) |
|
OP 1 |
Operations Team 1 |
|
OP 1 (OC) |
Operations Team 1 (OC) |
|
OP 2 |
Operations Team 2 |
|
OP 2 (OC) |
Operations Team 2 (OC) |
|
OP 3 |
Operations Team 3 |
|
OP 3 (OC) |
Operations Team 3 (OC) |
|
OP 4 |
Operations Team 4 |
|
OP 4 (OC) |
Operations Team 4 (OC) |
|
OPA (OC) |
Office of Public Affairs (OC) |
|
OPB (ORA) |
Operations and Policy Branch (Office of Regulatory Affairs) |
|
OPD (OC) |
Office of Orphan Products Development (OC) |
|
OPDFB (CFSAN) |
Office of Plants, Dairy Foods and Beverages (CFSAN) |
|
OPDP |
Office of Prescription Drug Promotion (CDER) (formerly Division of Drug Marketing, Advertisement and |
|
OPF |
Official Personnel Folder |
|
OPFIT (NCTR) |
Office of Planning, Finance and Information Technology (NCTR) |
|
OPHEP |
Office of Public Health Emergency Preparedness |
|
OPI |
Office of Planning and Informatics |
|
OPL |
Office of PLanning |
|
OPL (OC) |
Office of Planning (OC) |
|
OPM |
Office of Personnel Management |
|
OPMAD |
Orthopedic Physical Medicine and Anesthesiology Devices Branch |
|
OPMAD (CDRH) |
Orthopedic Physical Medicine and Anesthesiology Devices Branch (CDRH) |
|
OPO |
Organ Procurement Organization |
|
OPPB |
Office of Policy Planning and Budget |
|
OPPL |
Office of Policy, Planning, and Legislation |
|
OPPL (OC) |
Office of Policy, Planning and Legislation (OC) |
|
OPS |
Office of Pharmaceutical Science |
|
OPS (CDER) |
Office of Pharmaceutical Science (CDER) |
|
OPT |
Office of Pediatric Therapeutics |
|
OPT (OC) |
Office of Pediatric Therapeutics (OC) |
|
OPV |
Oral Polio Vaccine |
|
OQ |
Operational Qualification |
|
OR |
Office of Research |
|
OR (CVM) |
Office of Research (CVM) |
|
ORAC |
Oxygen-Radical Absorbance Capacity |
|
ORADSS |
Office of Regulatory Affairs Reporting, Analysis, and Decision Support System |
|
Orange Book |
Approved Drug Products with Therapeutic Equivalence Evaluations |
|
ORD |
Office of Research and Demonstrations |
|
ORI |
Office of Research Integrity |
|
ORISE |
Oak Ridge Institute for Science and Education |
|
ORL-DO (ORA) |
ORLando District Office (Office of Regulatory Affairs) |
|
ORM (ORA) |
Office of Resource Management (ORA) |
|
ORNL |
Oak Ridge National Laboratory's |
|
ORO |
Office of Regional Operations |
|
ORO (ORA) |
Office of Regional Operations (ORA) |
|
ORP (CDER) |
Office of Regulatory Policy (Center for Drug Evaluation and Research) |
|
ORP (CFSAN) |
Office of Regulations and Policy (Center for Food Safety and Applied Nutrition) |
|
ORPS |
Office of Real Property Services |
|
ORPS (OC) |
Office of Real Property Services (OC) |
|
ORPSS |
Office of Regulations, Policy, and Social Sciences |
|
ORPSS (CFSAN) |
Office of Regulations, Policy and Social Sciences (CFSAN) |
|
ORR |
Objective Response Rate |
|
ORS (CFSAN) |
Office of Regulatory Science (CFSAN) |
|
ORTF |
Obesity Research Task Force |
|
ORWH |
Office Research into Women's Health (NIH) |
|
OS (CDER) |
Operations Staff (CDER) |
|
OS (CFSAN) |
Office of Seafood (CFSAN) |
|
OS (OC) |
Operations Staff (OC) |
|
OSAS (CFSAN) |
Office of Scientific Analysis and Support (CFSAN) |
|
OSB (CDRH) |
Office of Surveillance and Biometrics (CDRH) |
|
OSB (CFSAN) |
Office Services Branch (CFSAN) |
|
OSC (CVM) |
Office of Surveillance and Compliance (CVM) |
|
OSCAR |
ORACLE System for Center Automation and Retrieval |
|
OSCI |
Office of SCIence |
|
OSCI (CFSAN) |
Office of Science (CFSAN) |
|
OSD-HD |
Office of the Secretary of Defense for Homeland Defense |
|
OSDB (CDRH) |
Orthopedic Spine Devices Branch (CDRH) |
|
OSE |
Office of Surveillance and Epidemiology |
|
OSE (CDER) |
Office of Surveillance and Epidemiology (CDER) |
|
OSEL (CDRH) |
Office of Science and Engineering Laboratories (CDRH) |
|
OSG |
Office of the Surgeon General |
|
OSHA |
Occupational Safety and Health Administration (U.S. Department of Labor) |
|
OSHC (OC) |
Office of Science and Health Coordination (OC) |
|
OSHI (OC) |
Office of Special Health Issues (OC) |
|
OSHRC |
Occupational Safety and Health Review Commission |
|
OSMP |
Office of Special Medical Programs |
|
OSO |
Office of Security Operations |
|
OSO (OC) |
Office of Security Operations (OC) |
|
OSP |
Office of Suicide Prevention |
|
OSS |
Office of Shared Services |
|
OSS (OC) |
Office of Shared Services (OC) |
|
OST |
Office Services Team |
|
OST (CFSAN) |
Office Services Team (CFSAN) |
|
OSTP |
Office of Science and Technology Policy |
|
OTC |
Over The Counter (medications not requiring a prescription) |
|
OTCDHFB (CDER) |
OTC Drugs and Health Fraud Branch (CDER) |
|
OTCOM (CDER) |
Office of Training and Communications (CDER) |
|
OTFP |
Other Than a Food Processing facility |
|
OTR (CDER) |
Office of Testing and Research (CDER) |
|
OTRR (CBER) |
Office of Therapeutics Research and Review (CBER) |
|
OTS (CDER) |
Office of Translational Sciences (CDER) |
|
OVI |
Organic Volatile Impurity |
|
OVR |
Operations Variance Report |
|
OVRR |
Office of Vaccines Research and Review |
|
OVRR (CBER) |
Office of Vaccines Research and Review (CBER) |
|
OVST |
Operations and Veterinary Support Team |
|
OVST (CFSAN) |
Operations and Veterinary Support Team (CFSAN) |
|
OWH (OC) |
Office of Women's Health (OC) |
|
P & PC |
production and process controls |
|
P&PC |
Production and Process Control |
|
PA |
Physical Activity |
|
PAAB |
Pharmaceutical Advertising Advisory Board (Canada) |
|
PAB (CFSAN) |
Product Adulteration Branch (CFSAN) |
|
PACE |
Patient-centered Assessment and Counseling for Exercise |
|
PAD |
Pharmacologically Active Drug |
|
PADE |
Postmarketing Adverse Drug Experience |
|
PADER |
Periodic Adverse Drug Experience Report |
|
PAER |
Preliminary Adverse Event Report |
|
PAFA |
Priority-Based Assessment of Food Additives |
|
PAG |
Project Advisory Group |
|
PAGE |
PolyAcrylimide Gel Electrophoresis |
|
PAHO |
Pan American Health Organization |
|
PAI |
Pre-Approval Inspection |
|
PAIS |
Public Affairs and Information Staff |
|
PAIS (ORA) |
Public Affairs and Information Staff (ORA) |
|
PAITS |
Pre-Approval Inspection Tracking System |
|
PAL |
Public Affairs Liaison |
|
PAM |
Pesticide Analytical Manual |
|
PAMP |
Post-approval Monitoring System |
|
PAMS |
Post-Approval Monitoring System |
|
PAO |
Public Affairs Officer |
|
PAP |
Patient Assistance Program |
|
PARN |
Problem/Action Request Notice |
|
PARQ |
Physical Activity Readiness Questionnaire |
|
PARS |
Program Activities Review Staff |
|
PARS (CDER) |
Program Activities Review Staff (CDER) |
|
PART |
Program Assessment Rating Tool |
|
PAS (CDRH) |
Premarket Approval Section (CDRH) |
|
PAT |
Process Analytical Technology Initiative |
|
PB |
Planning Branch |
|
PB (CDRH) |
Planning Branch (CDRH) |
|
PB (CFSAN) |
Pathology Branch (Center for Food Safety and Applied Nutrition) |
|
PBM |
Pharmacy Benefits Management (or Manager) |
|
PBSC |
Peripheral Blood Stem Cell |
|
PC |
Personal computer (host) |
|
PCBE |
President's Council on Bioethics |
|
pcbs |
polychlorinated biphenyls |
|
PCP |
Pneumocystis Carinii Pneumoniae |
|
PCR |
Polymerase Chain Reaction |
|
PCS |
Permanent Change Of Station. Reassignment To A Different Duty Station. |
|
PDA |
Prescription Drug Advertising |
|
PDB (CDER) |
Prescription Drugs Branch (Center for Drug Evaluation and Research) |
|
PDCA |
Plan-do-check-action |
|
PDCS |
Policy Development and Coordination Staff |
|
PDCS (OC) |
Policy Development and Coordination Staff (OC) |
|
PDE |
Permitted Daily Exposure |
|
PDE-4 |
PhosphoDiEsterase-4 |
|
PDF |
Portable Document Format (created by Adobe Acrobat) |
|
PDI |
Post-Donation Information |
|
PDLB |
Pacing, Defibrillator, and Leads Branch |
|
PDLB (CDRH) |
Pacing, Defibrillator and Leads Branch (CDRH) |
|
PDMA |
Prescription Drug Marketing Act of 1988 |
|
PDMP |
Prescription Drug Monitoring Program |
|
PDO |
Protected Designation of Origin |
|
pdq |
physician data query information from national cancer institute |
|
PDS (CDER) |
Project Development Staff (CDER) |
|
PDUFA |
Prescription Drug User Fee Act of 1992 |
|
PEB (CBER) |
Planning and Evaluation Branch (CBER) |
|
PEB (CDRH) |
Program Enforcement Branch (CDRH) |
|
PEB (ORA) |
Program Evaluation Branch (ORA) |
|
PEB 1 (CDRH) |
Postmarket Evaluation Branch 1 (Center for Devices and Radiological Health) |
|
PEB 2 (CDRH) |
Postmarket Evaluation Branch 2 (Center for Devices and Radiological Health) |
|
PELT |
Product Evaluation and Labeling Team |
|
PELT (CFSAN) |
Product Evaluation and Labeling Team (CFSAN) |
|
PEP |
Performance Evaluation Plan |
|
PER |
Pharmaceutical Evaluation Report |
|
Per Diem |
Per Day allowance for daily travel expenses |
|
PERI |
Pharmaceutical Education & Research Institute |
|
PERT |
Product-enhanced Reverse Transcriptase |
|
PERV |
Porcine Endogenous Retrovirus |
|
PETA |
People for the Ethical Treatment of Animals |
|
PETG |
Polyethylene Terephthalate Glycol |
|
PFGE |
Pulsed-Field Gel Electrophoresis |
|
PFL |
Professional Flexible Labeling |
|
PFO |
Principal Federal Official |
|
PFS |
Piper Fatigue Scale |
|
PGB |
Policy Guidance Branch |
|
PGB (CFSAN) |
Policy Guidance Branch (CFSAN) |
|
PHA |
Public Health Advisory |
|
PHI |
Protected Health Information |
|
PHIN |
Public Health Information Network |
|
PHN |
Population, Health, and Nutrition Center |
|
PHPPO |
Public Health Practice Program Office |
|
PHPS |
Public Health Prevention Service |
|
PhRMA |
Pharmaceutical Research and Manufacturers of America (formerly PMA, Pharmaceutical Manufacturers Association) |
|
PHS |
Public Health Service (U.S.) |
|
PHSA |
Public Health Service Act of 1944 |
|
PHTN |
Public Health Training Network |
|
PIB |
Program Inspection Branch |
|
PIB (CBER) |
Program Inspection Branch (CBER) |
|
PIC |
Pharmaceutical Inspection Convention |
|
PIC/S |
Pharmaceutical Inspection Co-operation Scheme |
|
PICNIC |
Professionals and Citizens Network for Integrated Care |
|
PIFSI |
Produce and Imported Foods Safety Initiative |
|
PIM |
Product Information Management |
|
PIN |
Personal Identification Number |
|
PIP |
Plant-Incorporated Protectant |
|
PIV |
Personal Identify Verification |
|
PK |
Pharmacokinetics |
|
PKA |
Prekallikrein Activator |
|
PKI |
Public Key Infrastructure (cryptography) |
|
PKLN |
ParkLawn Building |
|
PKU |
Phenylketonuria |
|
PLAS |
Prior Label Approval System |
|
PLF |
Product Licensing Framework (Canada) |
|
PLI |
Pre-License Inspection |
|
PLR |
Physician Labeling Rule |
|
PMA# |
Pre-Market Approval device number |
|
PMAP |
Performance Management Appraisal Program |
|
PMB |
Program Management Board |
|
PMC |
Post-Marketing Commitment |
|
PMCC |
Project Management Coordinating Committee |
|
PMF |
Public Master File |
|
PMHS |
Pediatric and Maternal Health Staff |
|
PMHS (CDER) |
Pediatric and Maternal Health Staff (CDER) |
|
PMN |
Pre-Market Notification |
|
PMN# |
Pre-Market Notification number of a device |
|
PMOA |
Primary Mode Of Action |
|
PMPRB |
Patented Medicine Prices Review Board |
|
PMS (CDRH) |
Program Management Staff (CDRH) |
|
PMS (OC) |
Print Media Staff (OC) |
|
PMSB |
Pharmaceutical and Medical Safety Bureau (Japan) |
|
PMSB (CBER) |
Program Management Services Branch (Center for Biologics Evaluation and Research) |
|
PMSB (CDER) |
Program Management Services Branch (Center for Drug Evaluation and Research) |
|
PMSC |
Pre-Market Surveillance and Compliance |
|
PN |
Product Name |
|
PNC |
Prior Notice Center |
|
PNC (ORA) |
Prior Notice Center (ORA) |
|
PNIG |
Patient Narrative Information Guide |
|
PNNL |
Pacific Northwest National Laboratory (DOE) (US) |
|
PNR |
Passenger Name Record |
|
PNS |
Premarket Notification Section |
|
PNS (CDRH) |
Premarket Notification Section (CDRH) |
|
PNSI |
Prior Notice System Interface |
|
PO |
Per Os (by mouth) |
|
POA |
privately owned automobile |
|
POB |
Program Operations Branch |
|
POB (CBER) |
Program Operations Branch (CBER) |
|
POC |
Point Of Contact |
|
POS |
Point Of Sale.Retail term, being the physical point at which products are displayed on shelves or paid for at the checkout, as in the EPOS acronym. |
|
POS (CBER) |
Program Operation Staff (CBER) |
|
POS (CDRH) |
Program Operations Staff (CDRH) |
|
POV |
Privately-Owned Vehicle. A Soldier's Personal Automobile. |
|
POWER |
Petition Optical Workflow, Exchange, and Retrieval |
|
PP |
Pay Period |
|
PPB (CFSAN) |
Plant Products Branch (CFSAN) |
|
PPC |
Production and Process Controls |
|
PPE |
Pay Period Ending |
|
PPIA |
Poultry Products Inspection Act |
|
PPP |
Point-to-Point Protocol |
|
PPQ |
Plant Protection and Quarantine |
|
PPS |
Policy and Publications Staff |
|
PPS (CBER) |
Policy and Publications Staff (CBER) |
|
PPSR |
Proposal for Pediatric Studies Request |
|
PPT |
Plasma Preparation Tube |
|
PPTA |
Plasma Protein Therapeutics Association |
|
PPTP |
Point-to-Point Tunneling Protocol |
|
PPV |
Patient Profile Viewer |
|
PPWMB |
Program Planning and Workforce Management Branch |
|
PPWMB (ORA) |
Program Planning and Workforce Management Branch (ORA) |
|
PQAS |
Pharmaceutical Quality Assessment System |
|
PQG |
Pharmaceutical Quality Group |
|
PQLS |
Product Quality Laboratory Staff |
|
PQLS (CBER) |
Product Quality Laboratory Staff (CBER) |
|
PQRI |
Product Quality Research Institute |
|
PR |
Public Relations |
|
PR (CBER) |
Product Review Branch (CBER) |
|
PRA |
Paperwork Reduction Act of 1995 |
|
PRB (CBER) |
Product Release Branch (CBER) |
|
PRB (CFSAN) |
Pathology Branch (CFSAN) |
|
PREA |
Pediatric Research Equity Act of 2003 |
|
PRIM & R |
Public Responsibility in Medicine and Research |
|
PSN |
Patient Safety News (FDA) |
|
PSNI |
Pharmaceutical Society of Northern Ireland |
|
PSP |
Physician Special Pay |
|
PSS |
Patient Safety Staff |
|
PSS (CDRH) |
Patient Safety Staff (CDRH) |
|
PSSB |
Program Support Services Branch |
|
PSSB (CFSAN) |
Program Support Services Branch (CFSAN) |
|
PST |
Porcine Somatotropin |
|
PSUR |
Periodic Safety Update Report |
|
PT |
Preferred Term |
|
PTB |
Pharmacology and Toxicology Branch |
|
PTC |
Points to Consider |
|
PTC |
Parklawn Training Center |
|
PTCC |
Pharmacology and Toxicology Coordinating Committee |
|
PTE |
Patent Term Extension |
|
PTEI |
Pittsburgh Tissue Engineering Initiative |
|
PTFE |
Polytetrafluroethylene |
|
PTK |
PhotoTerapeutic Keratectomy |
|
PTO |
Patent and Trademark Office (U.S. Department of Commerce) |
|
PTR |
Platelet Transfusion Reaction |
|
PTS |
Product Testing Section |
|
PTS (CBER) |
Product Testing Section (CBER) |
|
PTU |
Propylthiouracil |
|
PUD |
Peptic Ulcer Disease |
|
PUFI |
Packed Under Federal Inspection |
|
PV |
Process Validation |
|
PVC |
Polyvinyl Chloride |
|
PVDB |
Peripheral Vascular Devices Branch |
|
PVDB (CDRH) |
Peripheral Vascular Devices Branch (CDRH) |
|
PWS |
Performance Work Statement |
|
Q & A |
questions and answers |
|
Q1H |
Every 1 Hour |
|
Qa |
Center for Quality Assurance in International Education |
|
QAO |
Quality Assurance Office |
|
QAS (CBER) |
Quality Assurance Staff (CBER) |
|
QAT (CBER) |
Quality Assurance Team (CBER) |
|
QAU (CFSAN) |
Quality Assurance Unit (CFSAN) |
|
QBD |
Quality by Design |
|
QbR |
Question-Based Review |
|
QC |
Quality Control |
|
QCP |
Quality Control Program |
|
QD |
Quaque in Die (once daily) |
|
qhs |
quaque hora somni (every night at bedtime) |
|
QID |
Quater In Die (Four Times a Day) |
|
QIJ |
Quality Inspection Journal |
|
QIS-P |
Quality Information Summary - Pharmaceuticals |
|
QL |
Quality of Life |
|
QMIS |
Quality Management Information System |
|
QMS |
Quality Management System |
|
QMs |
Quality Management Staffing |
|
QMS (CDER) |
Quality Management Staff (CDER) |
|
QNS |
Quantity Not Sufficient |
|
QOD |
Quaque Altere Die (take every other day) |
|
QOL |
Quality of Life |
|
QoS |
Quality Overall Summary |
|
QP |
Qualified Person |
|
QS |
Quality System |
|
QSAR |
Quantitative Structure Activity Relationship |
|
QSI |
Quality Step Increase |
|
QSIT |
Quality System Inspection Technique |
|
QSR |
Quality System Regulation |
|
QSR |
Quality System Representative |
|
QSR |
Quality System Record |
|
QTV |
Qualified Through Verification |
|
QU |
Quality Unit |
|
QWL |
Quality of Work Life |
|
R & D |
research and development |
|
R & E |
Recall and Emergency (ORA) |
|
R & W |
recreation and welfare |
|
R&D |
Research & Development |
|
R&E |
Recall and Emergency |
|
R&W |
Recreation and Welfare |
|
R-CHOP |
Drug combination that includes rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone |
|
RA |
Rheumatoid Arthritis |
|
RAA |
Research Across America (various locations) |
|
RAC |
Reviewer Affairs Committee |
|
RAC |
Raw Agricultural Commodity |
|
RAC |
Recombinant-DNA Advisory Committee |
|
RACC |
Reference Amount Customarily Consumed |
|
RACT (CFSAN) |
Risk Assessment Coordination Team (CFSAN) |
|
RAD |
Rapid Application Design |
|
RADAR |
Radio Detecting and Ranging |
|
RADAR |
Risk Assessment of Drugs Analysis and Response |
|
RAE |
Remedial Action Exemption |
|
RAM |
random-access memory |
|
RAM |
Reporting and Analysis Module |
|
RAMB |
Research Animal Medicine Branch |
|
RAMP |
Remedial Action Management Program |
|
RBC |
Red Blood Cells |
|
RBRVS |
Resource-Based Relative Value Scale |
|
RCC |
Research Coordinating Committee |
|
RCH |
Remove Clinical Hold |
|
RCHSA |
Radiation Control for Health and Safety Act of 1968 |
|
RCR |
Risk Control Review |
|
RCR |
Replication Competent Retrovirus |
|
RCS |
Records Control Schedule |
|
RCS |
Regulations Coordination Staff |
|
RCS (CFSAN) |
Regulations Coordination Staff (CFSAN) |
|
RCT |
ReCall Team |
|
RCT |
randomized controlled trial |
|
RCT (CFSAN) |
Recall Team (CFSAN) |
|
RD |
Registration Dossier |
|
RDA |
Recommended Daily Allowance |
|
RDB |
Radiological Devices Branch |
|
RDB (CDRH) |
Radiological Devices Branch (CDRH) |
|
RDBMS |
Relational Database Management System |
|
RDE |
Remote Data Entry |
|
RDI |
Reference Daily Intake |
|
RDNA |
Recombinant Deoxyribonucleic Acid |
|
RDT |
rising dose tolerance |
|
RDTS |
Reproductive and Developmental Toxicology Subcommittee (CDER) |
|
REDS-II |
Retrovirus Epidemiology Donor Study Two |
|
REE |
Research, Education, and Economics |
|
REG |
Drug REGistration number |
|
reg neg |
regulatory negotiation |
|
ReGo |
Reinventing the United States Government |
|
REIS |
Regional Economic Information System |
|
REMS |
Risk Evaluation and Mitigation Strategy |
|
REMS: |
Risk Evaluation and Mitigation Strategies |
|
RES |
Recall Enterprise System (ORA) |
|
RES |
Residence |
|
RES (OC) |
Regulations Editorial Section (OC) |
|
RESNA |
Rehabilitation Engineering and Assistive Technology Society of North America |
|
RFA |
Request For Application |
|
RFCPCS |
Retail Food and Cooperative Programs Coordination Staff |
|
RFCPCS (CFAN) |
Retail Food and Cooperative Programs Coordination Staff (CFSAN) |
|
RFD |
Request for Designation |
|
RFDD |
Regional Food and Drug Director |
|
RFI |
Request For Information. Sales department shorthand. Special priority when use in conjunction with RFN (see below). |
|
RFID |
Radio Frequency Identification |
|
RFP |
Request For Proposal |
|
RFPT |
Retail Food Protection Team |
|
RFPT (CFSAN) |
Retail Food Protection Team (CFSAN) |
|
RFR |
Reportable Food Registry |
|
RH |
responsible head |
|
RH |
Relative Humidity |
|
RIA |
Radio Immuno-Assay |
|
RIAS |
Regulatory Impact Analysis Statement |
|
RIBAÖ |
recombinant immunoblot assay (Chiron «) |
|
RIBAル |
recombinant immunoblot assay (Chiron ᆴ) |
|
RIC |
Resident in Charge |
|
RICHS |
Rural Information Center Health Service |
|
RIF |
reduction-in-force |
|
RIHSC |
Research Involving Human Subjects Committee (FDA) |
|
RIM |
reference information model (HL7) |
|
RIMS |
Regulatory Information Management Staff |
|
RIPA |
radioimunoprecipitation assay |
|
RIS |
Retroviral Immunology Section |
|
RIS |
Regulatory Information Specialist |
|
RIS (CBER) |
Retroviral Immunology Section (CBER) |
|
RIT |
RELOCATION INCOME TAX |
|
RKW1 |
Rockwall Building I |
|
RKW2 |
Rockwall Building II |
|
RL |
regulatory letter (FDA post-audit letter) |
|
RLD |
Reference Listed Drug |
|
RM |
Raw Material |
|
RMAB (CDRH) |
Risk Management and Analysis Branch (CDRH) |
|
RMB (CBER) |
Resource Management Branch (CBER) |
|
RMCC |
Review Management Coordinating Committee |
|
RMS |
Review Management Staff |
|
RMS |
Regulatory Management System |
|
RMS |
Reference Member State |
|
RMS (CDER) |
Review Management Staff (CDER) |
|
RMS/BLA |
Regulatory Management System for the Biologics License Application |
|
RMT (CFSAN) |
Regulations Management Team (CFSAN) |
|
RNA |
Ribo Nucleic Acid |
|
ROA |
Read Only Access |
|
ROC |
receiver operating characteristic curve |
|
RODS |
Real-Time Outbreak & Disease Surveillance System |
|
RP |
Resident Post |
|
RPB (CDRH) |
Radiation Programs Branch (CDRH) |
|
RPM |
Regulatory Project Manager |
|
RPM |
Regulatory Procedures Manual (ORA) |
|
RPMB (CBER) |
Regulatory Project Management Branch (CBER) |
|
RPMCC |
Regulatory Project Management Coordinating Committee (CDER) |
|
RPMS (OC) |
Regulations Policy and Management Staff (OC) |
|
RPS |
Regulated Product Submissions |
|
RPS |
Regulatory Policy Staff |
|
RPS (CDER) |
Regulatory Policy Staff (CDER) |
|
RPSGB |
Royal Pharmaceutical Society of Great Britain |
|
RR |
Relative risk of death |
|
RR |
Recall Recommendation |
|
Rr |
Relative Risk Estimates |
|
RR |
repeatedly reactive |
|
RRCC |
Regional Response Coordination Center |
|
RRHR |
Regional Radiological Health Representative |
|
RRS |
Resource Reporting System |
|
RRS0S |
Regulatory Review Support Staff |
|
RRS16a0S |
Regulatory Review Support Staff |
|
RRSS (CDER) |
Regulatory Review Support Staff (CDER) |
|
RSB |
Recalls and Shortages Branch (CDER) |
|
RSB (CDER) |
Review Support Branch (CDER) |
|
RSGEMS (CFSAN) |
Regulations and Special Government Employees Management Staff (CFSAN) |
|
RSMB (CDRH) |
Reporting Systems Monitoring Branch (CDRH) |
|
RSO |
Radiation Safety Officer |
|
RSS |
RDF (Resource Data Framework) Site Summary |
|
RSS |
Rich Site Summary |
|
RSS |
Regulatory Support Staff |
|
RSS |
Really Simple Syndication |
|
RSS (CDER) |
Regulatory Support Staff (CDER) |
|
RSV |
Respiratory Syncytial Virus |
|
RSVIG |
respiratory synctial virus immune globulin |
|
RSVIGIV |
respiratory synctial virus immune globulin intravenous |
|
RSVP |
Resource reporting System Via Projects |
|
RTA |
Refusal To Accept |
|
RTAU |
Review and Technical Assistance Unit |
|
RTE |
Ready-To-Eat |
|
RTF |
Rich Text Format |
|
RTL |
Reproductive Toxicology Laboratory |
|
RTL (NCTR) |
Reproductive Toxicology Laboratory (NCTR) |
|
RTM |
Recall Team Member |
|
RTR |
Recall Termination Recommendation |
|
RU-486 |
Roussel Uclaf drug number 486 |
|
RUG |
Resource Utilization Group |
|
RUO |
Research Use Only |
|
RUP |
Restricted Use Pesticide |
|
RVIS |
Residue Violation Information System |
|
RVU |
Relative Value Unit |
|
RX |
prescriptions |
|
S & E |
safety and effectiveness |
|
S&E |
Safety and Effectiveness |
|
S&I |
Standards and Interoperability |
|
S/C |
Servings per Container |
|
S/L |
Sick Leave |
|
S/NDS |
Supplemental / New Drug Submission |
|
SA |
Sustained Action |
|
SAB |
Science Advisory Board (USEPA) |
|
SACD |
Special Assistant to the Center Director |
|
SACS |
Scientific Advisors and Consultants Staff |
|
SACX |
Secretary's Advisory Committee on Xenotransplantation |
|
SAD |
Single Ascending Dose |
|
SADR |
Suspected Adverse Drug Reaction |
|
SAE |
Serious Adverse Event |
|
SAER |
Standard Adverse Event Report Review (CDRH) |
|
SAF |
state access to FACTS |
|
SAI |
Single Active Ingredient |
|
SAL |
Sterility Assurance Level |
|
SAMHSA |
Substance Abuse and Mental Health Services Administration |
|
SAN-DO |
San Francisco District Office |
|
SAP |
Scientific Advisory Panel (SARCS) |
|
SAP |
Service Access Point |
|
SAPB (CFSAN) |
Shellfish and Aquaculture Policy Branch (CFSAN) |
|
SAR |
Search And Rescue |
|
SAR |
Specific Absorption Rate |
|
SARS |
Severe Acute Respiratory Syndrome |
|
SAS |
Symptom Assessment Scale |
|
SAT (CFSAN) |
Statistical Applications Team (CFSAN) |
|
SB (ORA) |
Systems Branch (ORA) |
|
SBA |
Summary Basis of Approval |
|
sba |
Small Business Administrations |
|
SBIR |
Small Business Initiated Research |
|
SBIR |
Small Business Innovation Research |
|
SBOA |
Summary Basis of Approval |
|
SBREFA |
Small Business Regulatory Enforcement Fairness Act |
|
SBRS |
SENIOR BIOMEDICAL RESEARCH SERVICE |
|
SC |
Subcutaneous |
|
SC (CDRH) |
Staff College (Center for Devices and Radiological Health) |
|
SC (CFSAN) |
Staff College (Center for Food Safety and Applied Nutrition) |
|
SCARP |
Supplier Corrective Action Report |
|
SCAW |
Scientists Center for Animal Welfare |
|
SCC |
Sector Coordinating Council for Food and Agriculture |
|
SCD |
Service Computation Date |
|
SCGD |
Special Controls Guidance Document |
|
SCL |
Symptom CheckList |
|
SCLIR |
Secondary Calibration Laboratories for Ionizing Radiation |
|
SCOGS |
Select Committee On GRAS (Generally Recognized As Safe) Substances |
|
SCR |
System Change Request |
|
SCRAG |
Senior Civilian Representative of the Attorney General, Department of Homeland Security |
|
SCRRB |
Scientific Compliance and Regulatory Review Branch |
|
SCRRB (ORA) |
Scientific Compliance and Regulatory Review Branch (ORA) |
|
SCSB |
Scientific Computer Support Branch |
|
SCSB (CFSAN) |
Scientific Computer Support Branch (CFSAN) |
|
SCT |
Society for Clinical Trials |
|
SCVIR |
Society for Cardiovascular and Interventional Radiologists (now SIR) |
|
SD |
Scientific Director |
|
SD |
Standard Deviation |
|
SDAB (CDER) |
Surveillance and Data Analysis Branch (CDER) |
|
SDCID |
Study Data Common Issues Document |
|
SDE |
State Designated Entity |
|
SDM |
Submission Data Model |
|
SDM |
System Development Methodology |
|
SDN |
Screening Deficiency Notice |
|
SDO |
Standards Development Organization |
|
SDOS |
Study Data Operations Subcommittee |
|
SDS |
Submission Data Standards |
|
SDS-PAGE |
Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis |
|
SDSC |
Study Data Standards Catalog |
|
SDSD |
Study Data Specifications Document |
|
SDSRCCG |
Study Data Standards Resources Change Control Group |
|
SDTM |
Study Data Tabulation Model |
|
SDWA |
Safe Drinking Water Act (as amended in 1986) |
|
SDWIS |
Safe Drinking Water Information System |
|
SE |
SUBSTANTIALLY EQUIVALENT |
|
SE |
Safe and Effective |
|
SE |
Salmonella Enteriditis |
|
SE |
Standard Error |
|
SEB |
Subsequent Entry Biologic |
|
SEC |
Securities and Exchange Commission (US) |
|
SECT 406B |
FDA Modernization Act section dealing with getting feedback from stakeholders |
|
SECT 505(b)(2) |
New drug application |
|
SEDS |
Shared Establishment Data Service |
|
SEER |
Surveillance, Epidemiology, and End Results |
|
SEIU |
Service Employees International Union |
|
SEND |
Standards for Exchange of Nonclinical Data |
|
SES |
Senior Executive Service |
|
SF |
Standard Form |
|
SFB |
Spore-Forming Bacteria |
|
SFLEO |
Senior Federal Law Enforcement Official |
|
SG |
Surgeon General |
|
SG |
Study Group |
|
SGA |
small for gestational age |
|
SGE |
special Government employee |
|
SGEMT (CFSAN) |
Special Government Employees Management Team (CFSAN) |
|
SGI |
Summer Genetics Institute |
|
SGO |
Surgeon General's Office |
|
She |
Safety, Health and Environmental |
|
SHEMS |
Safety, Health, and Environmental Management Section |
|
SHIE |
State Health Information Exchange |
|
SHOP |
Small Business Health Options Program |
|
SIA |
Strip Immunoblot Assay |
|
SIB (CDRH) |
Special Investigations Branch (CDRH) |
|
SID |
schedule identifier number (ORA AofC code) |
|
SID |
Source-to-Image Distance |
|
SIDS |
Sudden Infant Death Syndrome |
|
SIF |
Seafood HACCP Importer Form |
|
sIg |
strategic implementation group |
|
SIMCEN |
National Exercise Simulation Center |
|
SIMT |
Scientific, Internet/Intranet and Middle Tier (CFSAN) |
|
SIP |
Sterilization in Place |
|
SIP |
Survey of Institutionalized Persons |
|
SIP |
Summer Internship Program |
|
SIR |
Society of Interventional Radiology (formerly SCVIR) |
|
SIREN |
Scientific Information Retrieval and Exchange Network (CFSAN) |
|
SIS |
Streamlined Inspection System |
|
SISCF/SIFCF |
Survey of Inmates of State and Federal Correctional Facilities |
|
SISTIR |
Strategic Information Systems Technical Integration Resources |
|
SITP |
Strategic Information Technology Program |
|
SITP 5a8(OC) |
Strategic IT Programs (OC) |
|
SITP(OC) |
Strategic IT Programs (OC) |
|
SL |
Signature Line |
|
SLIP |
serial line internet protocol/point-to-point protocol |
|
SLK |
Statens Legemiddel Kontroll (Norwegian Medicines Control Authorities) |
|
SLO |
State Liaison Officer |
|
SLR |
Supplement Labeling Revision |
|
SM |
Starting material |
|
SMART |
Submission Management and Review Tracking |
|
SMB (OC) |
Space Management Branch (OC) |
|
SMCC |
Standards Management Coordinating Committee |
|
SMDA |
Safe Medical Devices Act of 1990 |
|
SME |
Significant Medical Event |
|
SME |
Subject Matter Expert |
|
SMF |
Site Master File |
|
SMG |
Staff Manual Guide |
|
SMO |
Site Management Organization |
|
SmPC |
Summary of Product Characteristics |
|
SMPS |
Standards Management Program Staff |
|
SMPS (CDRH) |
Standards Management Program Staff (CDRH) |
|
SMS |
Standards Management Staff (CDRH) |
|
SMS (CFSAN) |
Safety Management Staff (CFSAN) |
|
SMSB (CFSAN) |
Spectroscopy and Mass Spectrometry Branch (CFSAN) |
|
SMT |
Statistical Methodology Team |
|
SMT (CFSAN) |
Statistical Methodology Team (CFSAN) |
|
SMTP |
Simple Mail Transfer Protocol |
|
SN/AEMS |
Special Nutritional Adverse Events Monitoring System |
|
SNDA |
Supplemental New Drug Application |
|
SNIP |
Syndicat National de l'Industrie Pharmaceutique |
|
SNL |
Sandia National Laboratories |
|
SNOMED-RT |
Systematized Nomenclature of Medicine Reference Terminology |
|
SNRI |
Serotonin-Norepinephrine Reuptake Inhibitor |
|
SNS |
strategic national stockpile (CDC) |
|
SOAB (OC) |
Systems and Office Automation Branch (Immediate Office of the Commissioner) |
|
SOC |
System Organ Classes |
|
SOC |
System Organ Class |
|
SOC |
System Organ Classification |
|
SOCRA |
Society of Clinical Research Associates |
|
SOM |
Sensitivity of Method |
|
SOP |
Standard Operating Procedure |
|
SoPA |
Submission of Portion of Application |
|
SOPP |
Standard Operating Procedures and Policies |
|
sorn |
System of Records Notices |
|
SOW |
Statement Of Work |
|
SPA |
Special Protocol Assessment |
|
SPAC |
State Pharmaceutical Administration of China |
|
SPC |
Summary of Product Characteristics |
|
SPCS |
Safety Policy and Communications Staff |
|
SPCS (CDER) |
Safety Policy and Communications Staff (CDER) |
|
SPECT |
single-photon emission computed tomography |
|
SPGC |
Standards and Practice Guidelines Committee |
|
SPIE |
International Society for Optical Engineering |
|
SPL |
Structured Product Labeling |
|
SPLAT |
Structured Product Labeling Advisory Team |
|
SPLIEP |
Structured Product Labeling Interagency Executive Panel |
|
SPOTS |
Special Products On-line Tracking System |
|
SPPA |
Strategic Partnership Program Agroterrorism initiative |
|
SPR |
System Problem Report |
|
SPRC |
Seafood Products Research Center |
|
SPS |
Science and Policy Staff |
|
SPS |
Sanitary and PhytoSanitary |
|
SPS (CFSAN) |
Science and Policy Staff (CFSAN) |
|
SPTPB (CFSAN) |
Seafood Processing and Technology Policy Branch (CFSAN) |
|
SQ |
Subcutaneous |
|
SQA |
Society of Quality Assurance |
|
SQL |
Structured Query Language |
|
SR |
Significant Risk |
|
SR |
Sustained-Release |
|
SRAS |
Secure Remote Access Service |
|
SRCS |
Division of Surveillance, Research, and Communication Support |
|
SRD |
System Requirements Document |
|
SRD |
Swine Respiratory Disease |
|
SRD |
Significant Risk Device |
|
SRD |
Single Rising Dose |
|
SRM |
Specified Risk Material |
|
SRMS |
Specified Risk Materials |
|
SRS |
Spontaneous Reporting System |
|
SRS |
Substance Registration System |
|
SRS (CDER) |
Science and Research Staff (CDER) |
|
SS |
Serving Size |
|
SSA |
Sector-Specific Agencies |
|
SSA |
Social Security Administration |
|
SSAST (CFSAN) |
Senior Science Advisor's Staff (CFSAN) |
|
SSB |
Systems Support Branch |
|
SSB (CDRH) |
Systems Support Branch (CDRH) |
|
SSC |
Systems Steering Committee |
|
SSC |
Special search category |
|
ssca |
Statistics, Surveillance, and Control Archive (CDC) |
|
SSCT |
Swedish Society for Clinical Trials |
|
SSE |
Summary of Safety and Effectiveness |
|
SSED |
Summary of Safety and Effectiveness Data |
|
SSM |
Skin Surface Microscopy |
|
SSN |
Social Security Number |
|
SSOP |
Sanitation Standard Operating Procedures |
|
SSP |
Sector-Specific Plan |
|
SSRCR |
Suggested State Regulations for Control of Radiation |
|
SSRI |
Selective Serotonin Reuptake Inhibitor |
|
STA |
Special Temporary Authority |
|
STAI |
STrait Anxiety Inventory |
|
STAMP |
Systematic Technology Assessment of Medical Products |
|
STARS |
Submission Tracking and Reporting System |
|
STB (ORA) |
State Training Branch (ORA) |
|
STCD |
sterile connecting device |
|
STEPS |
System for Thalidomide Education and Prescribing Safety |
|
STN |
Submission Tracking Number |
|
STOP |
Safe Tables Our Priority |
|
STS |
Standards and Testing Staff |
|
STS (CBER) |
Standards and Testing Staff (CBER) |
|
Subpart H |
That subpart of 21 CFR Part 314 pertaining to accelerated approval of drugs |
|
SUD |
Single-Use Device |
|
SUD |
Sudden Unexpected Death |
|
Suds |
Single-Use Devices |
|
SUPAC |
Scale-Up and Postapproval Changes |
|
SUPAC-IR |
Scale-Up and Post-Approval Changes - Immediate Release |
|
SUPAC-MR |
scale-up and postapproval changes--modified release |
|
SUPAC-SS |
scale-up and postapproval changes--nonsterile solid |
|
SUPEC |
Scale-Up and Post-Approval Changes |
|
SUPEC-IR |
Scale-Up and Post-Approval Changes - Instant Release |
|
susar |
Suspected Unexpected Serious Adverse Reactions |
|
SVP |
small-volume parenteral |
|
SWAT |
Special Weapons and Tactics |
|
SWDB (CDRH) |
Software and Web Development Staff (CDRH) |
|
SX |
syndrome X |
|
T&A |
Time & Attendance |
|
T/PT |
Traceability/Product Tracing |
|
TA |
Travel Authorization |
|
TA |
Technology Administration |
|
TA |
Temporary Abeyance |
|
TAA |
transfusion-associated AIDS |
|
TAB (CDRH) |
Technical Assistance Branch (CDRH) |
|
TAB (OC) |
Travel Audit Branch (OC) |
|
TAH |
Transfusion-Associated Hepatitis |
|
TAS (NCTR) |
Technology Advancement Staff (NCTR) |
|
TAV |
travel authorizations and vouchers |
|
TAVC |
total aerobic viable count |
|
TB |
Tuberculosis Bacillus |
|
TB |
Tuberculosis |
|
tb |
Tuberculosis Background |
|
tb |
Tuberculosis Basic |
|
TBD |
To Be Determined |
|
TBLS |
Team Biologics Liaison Staff (CBER) |
|
TBP |
Therapeutic Biologic Product |
|
TBSB |
Therapeutics and Blood Safety Branch |
|
TBSB (CBER) |
Therapeutics and Blood Safety Branch (CBER) |
|
TBT |
Technical Barriers to Trade |
|
TCP/IP |
transmission control protocol/internet protocol |
|
TCS |
Temporary Change of Station |
|
TDD |
Telecommunications Device for the Deaf |
|
TDDB (CDRH) |
Television Design and Development Branch (CDRH) |
|
TDDS |
Transdermal Drug Delivery System |
|
TDI |
Tolerable Daily Intake |
|
TDS |
TOTAL DIET STUDY |
|
TDY |
temporary duty (non-unit-related personnel) |
|
TE |
Therapeutic Equivalence |
|
TEACA |
Trolox-Equivalent Antioxidant Capacity Assay |
|
TEAE |
Treatment-Emergent Adverse Event |
|
TEB |
Therapeutics Evaluation Branch |
|
TEB (CBER) |
Therapeutics Evaluation Branch (CBER) |
|
TEDS |
Treatment Episode Data Set |
|
TELECON |
TELEphone CONferencing |
|
TEP |
therapeutic exchange plasmapheresis |
|
TEPRSSC |
Technical Electronic Product Radiation Safety Standards Committee |
|
TERMIS |
Tissue Engineering and Regenerative Medicine International Society |
|
TESS |
Toxic Exposure Surveillance System |
|
TESS |
Treatment-Emergent Signs and Symptoms |
|
TFM |
Tentative Final Monograph |
|
TGA |
Therapeutic Goods Administration (Australia) |
|
TI |
Tolerable Intake |
|
TIACC |
Therapeutic Inequivalence Action Coordinating Committee |
|
TID |
three times a day |
|
TIND |
Treatment Investigational New Drug |
|
TK |
Toxicokinetics |
|
TLA |
Three-Letter Acronym |
|
TLC |
Thin Layer Chromatography |
|
TLV |
Threshhold Limit Value |
|
TMJ |
TemporoMandibular Joint (syndrome) |
|
TMO |
Trial Management Organization |
|
TNTC |
Too Numerous To Count |
|
TO |
table of oganization |
|
TO |
Transportation Officer |
|
TOA |
Total Obligation Authority |
|
TOC |
Total Organic Carbon |
|
TOI |
Trial Outcome Index |
|
TOL |
total organic carbon |
|
TOPOFF |
Top Officials |
|
TOPRA |
The Organisation for Professionals in Regulatory Affairs |
|
TOR |
Threshold of Regulation |
|
TPCC |
Therapeutic Products Classification Committee |
|
tpd |
TheTherapeutic Products Directorate |
|
TPDS |
Training and Professional Development Staff |
|
TPH |
Tropical Public Health |
|
TPI |
Tan Protection Index |
|
tplc |
Total Product Life Cycle |
|
TPN |
Total Parenteral Nutrition |
|
TPP |
Target Product Profile |
|
TQM |
Total Quality Management |
|
TRAC |
Tolerance Reassessment Advisory Committee |
|
TRALI |
transfusion-related acute lung injury |
|
Trans Net |
internet-based blood shortage reporting program (FDA) |
|
TRB |
Technical Review Board (MRR) |
|
TRI |
Toxics Release Inventory |
|
TRIMS |
Tissue Residue Information Management System |
|
TRO |
Temporary Restraining Order |
|
TROIF |
Total Recordable Occupational Illness Frequency |
|
TRU |
Temporary Recommendations for Use |
|
TRx |
Total number of Prescriptions |
|
TSA |
Transportation Security Administration |
|
TSCA |
Toxic Substances Control Act of 1976 |
|
TSCSB (CFSAN) |
Telecommunications and Scientific Computer Support Branch (CFSAN) |
|
TSD (OC) |
Travel Services Division (OC) |
|
TSE |
Transmissible Spongiform Encephalopathies |
|
TSEAC |
Transmissible Spongiform Encephalopathies Advisory Committee (CBER) |
|
TSH |
thyroid stimulating hormone |
|
TSOP |
Temperature Standard Operating Procedure |
|
TSOPs |
temperature standard operating procedures |
|
TSP |
Thrift Savings Plan |
|
TSS |
Transfusion Safety Study |
|
TSSRC |
Toxicology Study Selection and Review Committee |
|
TSSS (CDER) |
Technology Support Services Staff (CDER) |
|
TTTC |
Take Time To Care |
|
TTY |
TeleTYpewriter |
|
Turbo EIR |
Turbo Establishment Inspection Report (ORA) |
|
TV |
Travel Voucher |
|
TVA |
Tennessee Valley Authority (US) (electricity) |
|
TVBB |
Tumor Vaccines and Biotechnology Branch |
|
TVBB (CBER) |
Tumor Vaccines and Biotechnology Branch (CBER) |
|
TVC |
Total Viable Count |
|
twg |
Technical Working Groups |
|
U |
Units |
|
UA |
UrinAnalysis |
|
UADE |
Unanticipated Adverse Device Event |
|
UCB |
umbilical cord blood cells |
|
UCBU |
Umbilical Cord Blood Unit |
|
UCUM |
Unified Codes for Units of Measure (Regenstrief Institute) |
|
UDHQ |
Uniform Donor Health Questionnaire |
|
UDI |
Unique Device Identification |
|
UFC |
Unacceptable to Foreign Country |
|
UFMS |
Unified Financial Management System |
|
UIN |
Unique Identification Number |
|
Uk |
United Kingdom of Great Britain and Northern Ireland |
|
UKCCR |
United Kingdom Coordinating Committee on Cancer Research |
|
UL |
Underwriters Laboratories |
|
ULDB |
Urology and Lithotripsy Devices Branch |
|
ULDB (CDRH) |
Urology and Lithotripsy Devices Branch (CDRH) |
|
ULN |
upper limit of normal |
|
ULPA |
Ultra-Low Penetration Air |
|
UMCP |
University of Maryland-College Park |
|
UMDNS |
Universal Medical Device Nomenclature System |
|
UMLS |
Unified Medical Language System (NLM) |
|
UMS |
Unified Modeling Language (Object Management Group) |
|
UN |
unacceptable |
|
un |
United Narions |
|
UNAIDS |
Joint United Nations Program on HIV/AIDS |
|
UNESCO |
United Nations Educational, Scientific and Cultural Organization |
|
UNICEF |
United Nations International Children's Emergency Fund |
|
UNII |
Unique Ingredient Identifier |
|
UNOS |
United Network for Organ Sharing |
|
UPLC |
Ultra Performance Liquid Chromatography |
|
URAA |
Uruguay Round Agreements Act of 1994 |
|
URL |
Uniform Resource Locator |
|
URS |
User Requirement Specification |
|
US & R |
urban search and rescue |
|
USA |
United States Army |
|
USACE |
United States Army Corps of Engineers |
|
usaha |
United States Animal Health Association's |
|
USAID |
United States Agency for International Development |
|
USAMRIID |
U.S. Army Medical Research Institute for Infectious Diseases |
|
USAN |
United States Adopted Name |
|
USBR |
Bureau of Reclamation (U.S. Department of the Interior) |
|
USC |
United States Code (book of laws) |
|
USCA |
United States Code Annotated |
|
USCG |
United States Coast Guard |
|
USCS |
United States Customs Service |
|
USDA |
United States Department of Agriculture |
|
USFDA |
United States Food & Drug Administration |
|
USFS |
United States Forest Service (U.S. Department of Agriculture) |
|
USGS |
United States Geological Survey (DOI) |
|
USHIK |
United States Health Information Knowledge Base |
|
USIA |
United States Information Agency (changed To IIP) |
|
USITC |
United States International Trade Commission |
|
USJFCOM |
United States Joint Forces Command |
|
usms |
United States Marshals Service's |
|
USOPM |
United States Office of Personnel Management |
|
USP |
United States Pharmacopeia |
|
USP-DI |
United States Pharmacopeia-Drug Information |
|
USP-NF |
United States Pharmacopeia-National Formulary |
|
USPC |
United States Pharmacopeial Convention |
|
USPEA |
US Poultry & Egg Association |
|
usps |
United States Postal Services |
|
USPSTF |
United States Preventive Services Task Force |
|
USPTO |
United States Patent and Trademark Office |
|
USRDS |
United States Renal Data System |
|
USTFA |
U.S. Trout Farmers Association |
|
USTR |
United States Trade Representative |
|
USUHS |
Uniformed Services University of the Health Sciences |
|
V/V |
Verification/Validation |
|
VADM |
Vice Admiral |
|
VAERS |
Vaccine Adverse Event Reporting System |
|
VAI |
Voluntary Action Indicated (Food & Drug Administration postaudit inspection classification) |
|
VATS |
Vacancy Announcement Tracking System |
|
VATS |
Viral Activation Transfusion Study |
|
VAX |
Virtual Address Extension |
|
VBPF |
vegetative bacteria, protozoa and viruses |
|
VBPV |
Vegetative Bacteria, Protozoa, and Viruses |
|
VCH |
Travel VouCHer claim |
|
VCJD |
Variant Creutzfeldt-Jakob Disease |
|
VCOOL |
Voluntary Country-Of-Origin Labeling |
|
VCPR |
Veterinarian Client/Patient Relationship |
|
VCRP |
Voluntary Cosmetic Registration Program |
|
VCTB |
Vaccine Clinical Trials Branch |
|
VCTB (CBER) |
Vaccine Clinical Trials Branch (CBER) |
|
VDB (CDRH) |
Virology Devices Branch (CDRH) |
|
VE |
vaccine efficacy |
|
VEB (CBER) |
Vaccine Evaluation Branch (CBER) |
|
VEDB (CDRH) |
Vitreal and Extraocular Devices Branch (CDRH) |
|
VEE |
Venezuelan Equine Encephalomyelitis |
|
VetTrade |
Veterinarian Trading Post (website) |
|
VFD |
Veterinary Feed Directive |
|
VHA |
Veterans Health Administration's |
|
VHSP |
Viral Hepatitis Surveillance Program (CDC) |
|
VICH |
Veterinary International Committee on Harmonisation |
|
VIG |
Vaccinia Immune Globulin |
|
VISB (OC) |
Visual Information Services Branch (OC) |
|
VMAC |
Veterinary Medicine Advisory Committee |
|
VMB (CFSAN) |
Virulence Mechanisms Branch (CFSAN) |
|
VMD |
Veterinariae Medicinae Doctoris |
|
VMF |
Veterinary Master File |
|
VMO |
Veterinary Medical Officer |
|
VMP |
Validation Master Plan |
|
VMS |
Virtual Memory System |
|
VOAD |
Volunteer Organizations Active in a Disaster |
|
VPN |
Virtual Private Network (ATM) |
|
VPS |
Veterinary Product Safety |
|
VRBPAC |
Vaccines and Related Biological Products Advisory Committee |
|
VS |
Visiting Scientist |
|
VS (CBER) |
Validation Staff (CBER) |
|
VSB (CBER) |
Vaccine Safety Branch (CBER) |
|
VSD |
Vaccine Safety Datalink |
|
VSOF |
Visual Status of Funds |
|
VSPB |
Viral Special Pathogens Branch (CDC) |
|
VSS (NCTR) |
Veterinary Services Staff (NCTR) |
|
VVB (CBER) |
Viral Vaccines Branch (CBER) |
|
W3C |
World Wide Web Consortium |
|
WAE |
When Actually Employed |
|
WAG |
Widely Attended Gathering |
|
WAN |
Wide Area Network |
|
WAT (CFSAN) |
Worklife Analysis Team (CFSAN) |
|
WB |
Western Blot |
|
WBC |
White blood cells |
|
WBS |
Work Breakdown Structure |
|
WCHI |
Workers Compensation Health Initiative |
|
WEAC |
Winchester Engineering & Analytical Center |
|
WebSDM |
Web-based Submission Data Manager |
|
WEDA |
Workforce Equity and Diversity Action |
|
WEDI |
Workgroup for Electronic Data Interchange |
|
WFH |
World Federation of Hemophilia |
|
WFI |
Water For Injection (pharmaceutical Term) |
|
WG |
Wage Grade |
|
WHO |
World Health Organisation |
|
WHO-ART |
World Health Organisation Adverse Reaction Terminology |
|
WIB |
Western ImmunoBlot |
|
WIC |
Women, Infants, and Children nutrition program |
|
WIGI |
WithIn-Grade Increase |
|
WIN |
Welfare Information Network |
|
WISQARS |
Web-based Injury Statistics Query and Reporting System |
|
WITS |
Washington Interagency Telecommunications System |
|
WL |
Warning Letter (most serious Food & Drug Administration postaudit letter; demands immediate action within 15 days) |
|
WLF |
Washington Legal Foundation |
|
WMS (OC) |
Website Management Staff (OC) |
|
WNET |
Women's Network for Entrepreneurial Training |
|
WNME |
West Nile MeningoEncephalitis |
|
WNV |
West Nile Virus |
|
WO |
White Oak Campus |
|
WO (NCTR) |
Washington Office (NCTR) |
|
WOC I |
Woodmont Office Complex I (North) |
|
WOC II |
Woodmont Office Complex II (South) |
|
WONF |
With Other Natural Flavors |
|
WPADP |
Working Party on Automation and Data Processing |
|
WPC |
WordPerfect Character (mapping file) |
|
WPS (OC) |
Workforce Programs Staff (OC) |
|
WRAIR |
Walter Reed Army Institute of Research |
|
WRAMC |
Walter Reed Army Medical Center |
|
WSHSC |
water soluble, heat stable chemicals |
|
WSL |
Washington Seafood Laboratory |
|
WSL (CFSAN) |
Washington Seafood Laboratory (CFSAN) |
|
WTA |
WITHHOLDING TAX ALLOWANCE |
|
WtW |
Welfare-to-Work |
|
WWW |
World Wide Web |
|
WYSIWYG |
What You See Is What You Get (pronounced Wizzy-wig. See Entry For Derived Acronyms) |
|
X-SCID |
X-linked severe combined immunodeficiency disorder |
|
XDR-TB |
Extensively Drug-Resistant Tuberculosis |
|
XML |
Extensible Markup Language |
|
Y2K |
Year 2000 |
|
YTD |
Year To Date |
|
[NA]TAG |
[North American] Technical Advisory Group |
|
º |
section û shorthand symbol used to designate a section in a legal document; as in º201(m) of the FD& |
|
ºº |
sections û shorthand symbol used to designate sections in a legal document; as in ºº201(m), 301(k) o |
|
℮ |
estimated |
|
ᄃ |
Section; shorthand symbol used to designate a section in a legal document |
|
ᄃᄃ |
Sections; shorthand symbol used to designate sections in a legal document |
|