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Toxicology Pharmacology Acronym List
(Definition of
Acronyms and Abbreviations)
Acronym Glossary Acronyms Definition Abbreviation Dictionary Abbreviations
| 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 | Drug Price Competition
and Patent Term Restoration Act of 1984, aka Waxman-Hatch bill |
| 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 |