| |
| AAAS |
American Association for the Advancement
of Science |
| AABB |
American Association of Blood Banks |
| AACR |
American Association for Cancer Research
|
| AADA |
Abbreviated Antibiotic Drug Application |
| AAFP |
American Academy of Family Physicians |
| AAI |
American Academy of Immunologists |
| AAP |
American Association of Pathologists |
| AAPS |
American Association of Pharmaceutical
Scientists |
| ABPI |
Association of British Pharmaceutical
Industries |
| ACE |
Adverse Clinical Event |
| ACIL |
American Council of Independent
Laboratories |
| ACP |
Associates of Clinical Pharmacology |
| ACRA |
Associate Commissioner of Regulatory
Affairs |
| ACRPI |
Association for Clinical Research in the
Pharmaceutical Industry |
| ACS |
American Chemical Society |
| ACT |
Applied Clinical Trials |
| ADAMHA |
Alcohol, Drug Abuse and Mental Health
Administration |
| ADE |
Adverse Drug Event |
| ADI |
Acceptable Daily Intake |
| ADME |
Absorption, Distribution, Metabolism and
Excretion |
| ADP |
Automated Data Processing |
| ADR |
Adverse Drug Reaction |
| ADRS |
Adverse Drug Reporting System |
| AE |
Approvable |
| AE/ADE |
Adverse Event/Adverse Drug Event |
| AFDO |
Association of Food and Drug Officials |
| AHCPR |
Agency for Health Care Policy and
Research |
| AIM |
Active Ingredient Manufacturer |
| AIP |
Abbreviated Inspection Program |
| AMA |
American Medical Association |
| AMA-DE |
AMA Drug Evaluations |
| AMF |
Administrative Management of the Files |
| AmFAR |
American Foundation for AIDS Research |
| AMG |
West Germany Drug Law |
| ANADA |
Abbreviated New Animal Drug Application |
| ANDA |
Abbreviated New Drug Application |
| ANOVA |
Analysis of variances |
| AOAC |
Association of Official Analytical
Chemists |
| AP |
Approved (COMIS term) |
| APhA |
American Pharmaceutical Association |
| APHIS |
Animal and Plant Health Inspection
Service |
| AQL |
Acceptable Quality Level |
| ASA |
American Statistical Association |
| ASCO |
American Society for Clinical Oncology |
| ASCPT |
American Society for Clinical
Pharmacology and Therapeutics |
| ASM |
American Society for Microbiology |
| AT |
Active (COMIS term) |
| ATF |
Bureau of Alcohol, Tobacco, and Firearms
|
| AUC |
Area Under the Curve (an expression of
exposure) |
| BCE |
Beneficial Clinical Event |
| BID |
Two Times per Day |
| BIND |
Biological Investigational New Drug |
| BMB |
Bioresearch Monitoring Branch |
| BMI |
Body Mass Index |
| BPM |
Beats Per Minute |
| BRB |
Biomedical Research Branch |
| BSA |
Body Surface Area |
| BVC |
British Veterinary Codex |
| C & S |
Culture and Sensitivity |
| CA |
Chemical Abstracts |
| CAC |
Carcinogenicity Assessment Committee |
| CACE |
Committee for Advancement of Chemistry
Education |
| CANDA |
Computer Assisted New Drug Application |
| CAPLA |
Computer Assisted Product License
Application |
| CAPRA |
Canadian Association of Pharmaceutical
Regulatory Affairs |
| CAS |
Chemical Abstracts Service |
| CBC |
Complete Blood Count |
| CBCTN |
Community Based Clinical Trials Network |
| CBER |
Center for Biologics Evaluation and
Research |
| CCASE |
Coordinating Committee for Advancement
of Scientific Education |
| CCC |
Compliance Coordinating Committee (CDER)
|
| CCRC |
Certified Clinical Research Coordinator |
| CDC |
Center for Disease Control |
| CDER |
Center for Drug Evaluation and Research |
| CDRH |
Center for Devices and Radiological
Health |
| CE |
Continuing Education |
| CESS |
CDER Executive Secretariat Staff |
| CFR |
Code of Federal Regulations |
| CFSAN |
Center of Food Safety and Applied
Nutrition |
| CGMP |
Current Good Manufacturing Practice |
| CH |
Clinical Hold |
| CIB |
Clinical Investigator's Brochure |
| CID |
CTFA Cosmetic Ingredient Dictionary |
| CIOMS |
Council for International Organizations
of Medical Sciences |
| CIR |
Cosmetic Ingredient Review |
| CMC |
Chemistry and Manufacturing Controls |
| CMCCC |
Chemistry and Manufacturing Controls
Coordinating Committee (CDER) |
| CME |
Continuing Medical Education |
| CMMS |
Centers for Medicare and Medicaid Services |
| CNS |
Central Nervous System |
| COA |
Commissioned Officers Association |
| COE |
Code of Ethics |
| COMIS |
Center Office Management Information
System |
| COSTART |
Coding Symbols for Thesaurus of Adverse
Reaction Terms |
| CP |
Compliance Program |
| CPMP |
Committee for Proprietary Medicinal
Products |
| CPSC |
Consumer Product Safety Commission |
| CR |
Cross Reference (COMIS term) |
| CRA |
Clinical Research Associate |
| CRADA |
Cooperative Research and Development
Agreements |
| CRC |
Clinical Research Coordinator |
| CRF |
Case Report Form |
| CRO |
Contract Research Organization |
| CS |
Civil Service |
| CS |
Clinically Significant |
| CSDD |
Center for the Study of Drug Development
|
| CSI |
Consumer Safety Inspector |
| CSM |
Committee on Safety of Medicines |
| CSO |
Consumer Safety Officer (FDA) |
| CT |
Computerized Tomography |
| CTC |
Clinical Trial Certificate |
| CTX |
Clinical Trial Exemption Certification |
| CV |
Curriculum Vitae |
| CVM |
Center for Veterinary Medicine |
| CXR |
Chest X-ray |
| DAS |
Drug Abuse Staff |
| DAWN |
Drug Abuse Warning Network |
| DB |
Double-Blind |
| DDIR |
Division of Drug Information Resources |
| DDMAC |
Division of Drug Marketing, Advertising,
and Communications |
| DEA |
Drug Enforcement Administration |
| DEN |
Drug Experience Network |
| DES |
Division of Epidemiology and
Surveillance |
| DESI |
Drug Efficacy Study Implementation |
| DHHS |
Department of Health and Human Services |
| DIA |
Drug Information Association |
| DISD |
Division of Information Systems Design |
| DMF |
Drug Master File |
| DOD |
Department of Defense |
| DPC-PTR Act |
|
| DRG |
Diagnosis Related Groups |
| DSI |
Division of Scientific Investigations |
| DUR |
Drug Utilization Review |
| EA |
Environmental Assessment |
| EAB |
Ethical Advisory Board |
| EC |
European Commission |
| ECG |
Electrocardiogram |
| ECU |
European Currency Unit |
| ED |
Effective Dose |
| EEC |
European Economic Community |
| EEG |
Electroencephalogram |
| EEO |
Equal Employment Opportunity |
| EER |
Establishment Evaluation Request |
| EFPIA |
European Federal of Pharmaceutical
Industries Associations |
| EFTA |
European Free Trade Association |
| EIA |
Establishment Inspection Reports |
| EIR |
Establishment Inspection Report |
| ELA |
Establishment License Application |
| EO |
Executive Order |
| EOP1 |
End-of-phase 1 |
| EOP2 |
End-of-phase 2 |
| EORTC |
European Organization for Research and
Treatment of Cancer |
| EOS |
End of Study |
| EPA |
Environmental Protection Agency |
| EPL |
Effective Patent Life |
| EPMS |
Employee Performance Management System |
| ESS |
Executive Secretary and Staff |
| ETT |
Exercise Tolerance Test |
| EU |
European Union |
| EUP |
Experimental Use Permit |
| FACA |
Federal Advisory Committee Act 1972 |
| FAX |
Facsimile |
| FCC |
Federal Communications Commission |
| FCCSET |
Federal Coordinating Council for
Science, Engineering and Technology |
| FD & C Act |
Federal Food, Drug and Cosmetic Act |
| FDA |
Food and Drug Administration |
| FDA-SRS |
Spontaneous Reporting System of the Food
and Drug Administration |
| FDLI |
Food and Drug Law Institute |
| FFDCA |
Federal Food, Drug, and Cosmetic Act |
| FMD |
Field Management Directives |
| FOI |
Freedom of Information |
| FOIA |
Freedom of Information Act |
| FONSI |
Finding of No Significant Impact |
| FPL |
Final Printed Labeling |
| FR |
Federal Register |
| FRC |
Federal Records Center (Suitland) |
| FSIS |
Food Safety and Inspection Service |
| FTC |
Federal Trade Commission |
| FUR |
Follow up Request |
| GAO |
General Accounting Office |
| GATT |
General Agreement of Tariffs and Trade |
| GC |
General Counsel (FDA) |
| GCP |
Good Clinical Practice |
| GI |
Gastrointestinal |
| GLP |
Good Laboratory Practice |
| GMP |
Good Manufacturing Practice |
| GPRA |
Government Performance and Results Act |
| GRAS |
Generally Recognized as Safe |
| GRASE |
Generally Recognized as Safe and
Effective |
| GRP |
Good Review Practice |
| HAACP |
Hazard Analysis and Critical Control
Point (inspection technique) |
| HAI |
Health Action International |
| HF |
Routing code for mail to the Office of
the Commissioner of the FDA |
| HFD |
Routing code for mail to CDER |
| HFM |
Routing code for mail to CBER |
| HFS |
Routing code for mail to CFSAN |
| HFT |
Routing code for mail to NCTR |
| HFV |
Routing code for mail to CVM |
| HFZ |
Routing code for mail to CDRH |
| HHS |
Health and Human Services (Department
of) |
| HMO |
Health Maintenance Organization |
| HPB |
Health Protection Branch (Canada's
equivalent to the FDA) |
| HRG |
Health Research Group |
| HRRC |
Human Research Review Committee |
| HRSA |
Health Resources and Services
Administration |
| HX |
History |
| IACUC |
Institutional Animal Care and Use
Committee |
| IARC |
International Agency for Research on
Cancer |
| IC |
Informed Consent |
| IC |
Chemistry Information Amendment (COMIS
term) |
| ICD |
Informed Consent Document |
| ICH |
International Conference on
Harmonization |
| ICPEMC |
International Commission for Protection
Against Mutagens and Carcinogens |
| ICTH |
International Committee on Thrombosis
and Hemostases |
| IDE |
Investigational Device Exemption |
| IDR |
Idiosyncratic Drug Reaction |
| IDSMB |
Independent Data Safety Monitoring Board
|
| IG |
Inspector General |
| IHS |
Indian Health Service |
| IM |
Clinical Information Amendment (COMIS
term) |
| IM |
Intramuscular |
| INAD |
Investigational New Animal Drug |
| IND |
Investigational New Drug |
| INDA |
Investigational New Drug Application |
| INDC |
Investigational New Drug Committee |
| INN |
International Nonproprietary Name |
| IPCS |
International Program for Chemical
Safety |
| IPRA |
International Product Registration
Document |
| IPRO |
Independent Pharmaceutical Research
Organization |
| IRB |
Institutional Review Board |
| IRC |
Institutes Review Committee |
| IRG |
Initial Review Groups |
| IRS |
Identical, Related, or Similar |
| ISPE |
International Society for
Pharmacoepidemiology |
| IT |
Toxicology Information Amendment (COMIS
term) |
| IT |
Information Technology |
| ITCC |
Information Technology Coordinating
Committee (CDER) |
| IVD |
In Vitro Diagnostics |
| JCAH |
Joint Commission for the Accreditation
of Hospitals |
| JCAHO |
Joint Commission on Accreditation of
Health Care Organizations |
| JCPT |
Journal of Clinical Pharmacology and
Therapeutics |
| JCRDD |
Journal of Clinical Research and Drug
Development |
| JCRP |
Journal of Clinical Research and
Pharmacoepidemiology |
| JPMA |
Japan Pharmaceutical Manufacturers
Association |
| L & D |
Labor and Delivery |
| LAN |
Local Area Network |
| LD |
Lethal Dose |
| LD50 |
Lethal Dose (50%) |
| LEAA |
Law Enforcement Assistance
Administration |
| LERN |
Library Electronic Reference Network |
| LNC |
Labeling and Nomenclature Committee |
| LOA |
Letter of Agreement |
| LOC |
Level of Concern |
| LOCF |
Last Observation Carried Forward |
| LRC |
Lipid Research Clinic |
| LRI |
Lower Respiratory Infection |
| LTE |
Less Than Effective |
| MAPP |
Manual of Policy and Procedures |
| MBC |
Minimum Bactericidal Concentration |
| MDI |
Metered Dose Inhaler |
| MDR |
Medical Device Reporting |
| MEDLARS |
Medical Literature Analysis and
Retrieval System |
| MEDWATCH |
|
| MHW |
Ministry of Health and Welfare (Japan's
equivalent to the FDA) |
| MI |
Myocardial Infarction |
| MIC |
Minimum Inhibitory Concentration |
| MOU |
Memoranda of Understanding |
| MPCC |
Medical Policy Coordinating Committee
(CDER) |
| MRA |
Medical Research Associate |
| MRI |
Magnetic Resonance Imaging |
| MTD |
Maximum Tolerated Dose |
| NA |
Not Approvable |
| NADA |
New Animal Drug Application |
| NAF |
Notice of Adverse Findings |
| NAFTA |
North American Free Trade Agreement |
| NAHC |
National Advisory Health Council |
| NAI |
No Action Indicated |
| NAS |
National Academy of Sciences |
| NAS |
New Active Substance |
| NCCLS |
National Committee for Clinical
Laboratory Standards |
| NCE |
New Chemical Entity |
| NCHS |
National Center for Health Statistics |
| NCI |
National Cancer Institute |
| NCS |
Not Clinically Significant |
| NCTR |
National Center for Toxicological
Research |
| NCVIA |
National Childhood Vaccine Injury Act
(1986) |
| NDA |
New Drug Application |
| NDE |
New Drug Evaluation |
| NDS |
New Drug Study |
| NEJM |
New England Journal of Medicine |
| NF |
National Formulary |
| NHLBI |
National Heart, Lung, and Blood
Institute |
| NHW |
National Health and Welfare Department
(Canada's equivalent of DHHS) |
| NIA |
National Institute on Aging |
| NIAAA |
national Institute on Alcohol Abuse and
Alcoholism |
| NIAID |
National Institute of Allergy and
Infectious Disease |
| NIAMSD |
National Institute of Arthritis and
Musculoskeletal and Skin Diseases |
| NICHD |
National Institute of Child Health and
Human Development |
| NIDA |
National Institute of Drug Abuse |
| NIDCD |
National Institute of Deafness and other
Communication Disorders |
| NIDDKD |
National Institute of Diabetes And
Digestive And Kidney Diseases |
| NIDR |
National Institute of Dental Research |
| NIEHS |
National Institute of Environmental
Health Sciences |
| NIGMS |
National Institute of General Medical
Sciences |
| NIH |
National Institutes of Health |
| NIMH |
National Institute of Mental Health |
| NINDS |
National Institute of Neurological
Disorders and Stroke |
| NLM |
National Library of Medicine |
| NLEA |
Nutrition Labeling and Education Act
(1990) |
| NME |
New Molecular Entity |
| NMR |
Nuclear Magnetic Resonance |
| NOEL |
No Observed Effect Level |
| Non-Mem |
Non-linear Nixed Effect Model |
| NR |
No Reply Necessary (COMIS term) |
| NRC |
National Research Council |
| NRC |
Nuclear Regulatory Commission |
| NSAID |
Nonsteroidal Anti-inflammatory Drug |
| NSF |
National Science Foundation |
| NSR |
Nonsignificant Risk |
| NTP |
National Toxicology Program |
| OAI |
Official Action Indicated |
| OASH |
Office of the Assistant Secretary for
Health |
| OB-GYN |
Obstetrics-Gynecology |
| OC |
Office of the Commissioner |
| OC |
Office of Compliance (CDER) |
| OCD |
Office of the Center Director (CDER) |
| OCPB |
Office of Clinical Pharmacology and Biopharmaceutics
(CDER) |
| OD |
Right Eye |
| ODB |
Observational Database |
| ODE |
Office of Drug Evaluation (CDER) |
| OEA |
Office of External Affairs |
| OEB |
Office of Epidemiology and Biostatistics
(CDER) |
| OECD |
Organization for Economic Cooperation
and Development |
| OGC |
Office of the General Counsel |
| OGD |
Office of Generic Drugs (CDER) |
| OGE |
Office of Government Ethics |
| OHA |
Office of Health Affairs |
| OHRM |
Office of Human Resource Management |
| OLA |
Office of Legislative affairs |
| OM |
Office of Management (CDER) |
| OMB |
Office of Management and Budget |
| ONDC |
Office of New Drug Chemistry (CDER) |
| OP |
Open (COMIS term) |
| OP |
Office of Policy |
| OPA |
Office of Public Affairs |
| OPM |
Office of Personnel Management |
| OPRR |
Office of Protection for Research Risks |
| OPS |
Office of Pharmaceutical Science (CDER) |
| ORA |
Office of Regulatory Affairs |
| ORM |
Office of Review Management (CDER) |
| ORO |
Office of Regional Operations |
| OS |
Left Eye |
| OSHA |
Occupational Safety Health
Administration |
| OTA |
Office of Technology Assessment |
| OTC |
Over-the-Counter Drugs |
| OTCOM |
Office of Training and Communications
(CDER) |
| OTR |
Office of Testing and Research (CDER) |
| OU |
Both Eyes |
| P |
Priority |
| PAITS |
Pre-Approval Inspection Tracking System |
| PAR |
Postapproval Research |
| PC |
Personal Computer |
| PC |
Protocol Amendment- Change (COMIS term) |
| PCC |
Parklawn Computer Center |
| PCC |
Poison Control Center |
| PD |
Position Description |
| PD |
Pharmacodynamics |
| PDA |
Parenteral Drug Association |
| PDQ |
Physicians' Data Query |
| PDR |
Physician's Desk Reference |
| PDUFA |
Prescription Drug User Fee Act of 1992 |
| PEP |
Performance Evaluation Plan |
| PERI |
PhRMA Education and Research Institute |
| PET |
Positron Emission Tomography |
| PFT |
Pulmonary Function Tests |
| PhRMA |
Pharmaceutical Research and
Manufacturers of America |
| PHS |
Public Health Service |
| PI |
Package Insert (approved product
labeling) |
| PI |
Principal Investigator |
| PI |
Protocol Amendment- New Investigator
(COMIS term) |
| PK |
Pharmacokinetics |
| PLA/ELA |
Product License
Application/Establishment License Application |
| PM |
Project Manager |
| PMA |
Premarket Approval |
| PMCC |
Project Management Coordinating
Committee (CDER) |
| PMDIT |
Project Management |
| PMS |
Postmarketing Surveillance |
| PN |
Protocol Amendment- New Protocol (or
Pending Review) (COMIS term) |
| PO |
Per Os (by mouth) |
| PPA |
Poison Prevention Act |
| PPI |
Patient Package Insert |
| PPO |
Policy and Procedure Order |
| PR |
Pulse Rate |
| PRIM & R |
Public Responsibility in Medicine and
Research |
| PRN |
As Needed |
| PTCC |
Pharmacology/Toxicology Coordinating
Committee (CDER) |
| PUD |
Peptic Ulcer Disease |
| QA |
Quality Assurance |
| QAU |
Quality Assurance Unit |
| QC |
Quality Control |
| QD |
Once Daily |
| QID |
Four Times a Day |
| QL |
Quality of Life |
| QNS |
Quantity Not Sufficient |
| QOD |
Every Other Day |
| QoL |
Quality of Life |
| R & D |
Research and Development |
| RAC |
Reviewer Affairs Committee (CDER) |
| RADAR |
Risk Assessment of Drugs - Analysis and
Response |
| RAPS |
Regulatory Affairs Professionals Society
|
| RCC |
Research Coordinating Committee (CDER) |
| RCH |
Remove Clinical Hold |
| RCT |
Randomized Clinical Trial |
| RD |
Response to Request for Information
(COMIS term) |
| RDE |
Remote Data Entry |
| RDRC |
Radioactive Drug Research Committee |
| RDT |
Rising-dose tolerance |
| RIF |
Reduction In Force |
| RL |
Regulatory Letter |
| RMO |
Regulatory Management Officer |
| RTF |
The decision by the FDA to refuse to
file an application |
| RTF |
Refuse To File |
| RUG |
Resource Utilization Group |
| Rx |
Prescription |
| S |
Standard |
| SAE |
Serious Adverse Event |
| SAL |
Sterility Assurance Level |
| SBA |
Summary Basis of Approval |
| SC |
Study Coordinator |
| SC |
Sub-cutaneous |
| SCSO |
Supervisory Consumer Safety Officer |
| SD |
Standard Deviation |
| SE |
Standard Error |
| SEER |
Surveillance, Epidemiology, and End
Results (Registry of NCI) |
| SES |
Senior Executive Service |
| SMART |
Submission Management and Review
Tracking |
| SMDA |
Safe Medical Devices Act (1990) |
| SME |
Significant Medical Event |
| SNDA |
Supplemental New Drug Application |
| SOPs |
Standard Operating Procedures |
| SQ |
Subcutaneous |
| SRS |
Spontaneous Reporting System |
| SSM |
Skin Surface Microscopy |
| STT |
Short Term Tests |
| SUPAC |
Scale up and post approval changes |
| SX |
Symptoms |
| TID |
Three Times A Day |
| TIND |
Treatment IND |
| TK |
Toxicokinetics |
| TOP |
Topical |
| TSH |
Thyroid Stimulating Hormone |
| UA |
Urinalysis |
| UKCCR |
United Kingdom Coordinating Committee on
Cancer Research |
| UNESCO |
United Nations Educational Science and
Cultural Organization |
| USAN |
United States Adopted Name |
| USC |
United States Code |
| USCA |
U.S. Code Annotated |
| USDA |
United States Department of Agriculture |
| USP |
U.S. Pharmacopeia |
| USP-DI |
United States Pharmacopeia-Drug
Information |
| USP-NF |
United States Pharmacopeia-National
Formulary |
| USPC |
U.S. Pharmacopeial Convention |
| USUHS |
Uniformed Services University of the
Health Sciences |
| VA |
United States Department of Veterans
Affairs |
| VAI |
Voluntary Action Indicated |
| WD |
Withdrawn (COMIS term) |
| WHO |
World Health Organization |
| WI |
Inactive (COMIS term) |
| WL |
Warning Letter |
| WNL |
Within Normal Limits |
