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US Food & Drug Administration ( FDA ) Inspections - Pharmaceutical, Medical Device, Biologicals, Dietary Supplements, Food GMP, GLP, GCP, BIMO, QSIT, Pre-Approval, Quality System Inspections FDA inspections.com Glossary
regulatory acronyms
ACE Adverse Clinical Event
ADAA Animal Drug Availability Act
ADE Adverse Drug Event
ADR Adverse Drug Reaction
AF Administrative FIle
AMDUCA Animal Medicinal Drug Use Clarification Act
AMG West Germany Drug Law
ANADA Abbreviated New Animal Drug Application
ANDA Abbreviated New Drug Appplication
ANPR Advance Notice of Proposed Rulemaking
AQL Acceptable Quality Level
BCE Beneficial Clinical Event
BIMO Bioresearch Monitoring
BIND Biological Investigational New Drug
BVC British Veterinary Codex
BP British Pharmacopoeia
CA Chemical Abstracts
CAS Chemical Abstracts Service
CFR Code of Federal Regulations
CH Clinical Hold
CIB Clinical Investigator's Brochure
CIR Cosmetic Ingredient Review
CMC Chemistry and Manufacturing Controls
COE Code of Ethics
CP Compliance Program
CRA Clinical Research Assistant
CRADA Cooperative Research and Development Agreements
CRF Case Report Form

 

CRO

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CS Clinically Significant
CSO Consumer Safety Officer
CTC Clinical Trial Certificate
CTX Clinical Trial Exemption Certification
DB Double-Blind
DESI Drug Efficacy Study Implementation
DEN Drug Experience Network
DMF Drug Master File
DUR Drug Utilization Review
EA Environmental Assessment
EAB Ethical Advisory Board
EC European Commission
EH&S Environmental Health and Safety
ED Effective Dose
EIR Establishment Inspection Report
EO Executive Order
EOS End of Study
EPA Environmental Protection Agency
EPL Effective Patent Life
ER / ES Electronic Records / Electronic Signatures
EUP Experimental Use Permit
FDAMA Food and Drug Administration Modernization Act
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
FR Federal Register
GATT General Agreement on Trades and Tariffs
GLP Good Laboratory Practices
GMP Good Manufacturing Practices
GRAS Generally Recognized as Safe
GRASE Generally Recognized as Safe and Effective
GRP Good Review Practice
HAACP Hazard Analysis and Critical Control Point
IC Informed Consent
ICH International Conference of Harmonization
IDE Investigational Device Exemption
INAD Investigational New Animal Drug
IND Investigational New Drug
IRB Institutional Review Board
IVD In Vitro Diagnostics
LIMS Laboratory Information Management Systems
MAPP Manual of Policy and Procedures
MDR Medical Device Reporting
MOA Memorandum of Agreement
MON Memorandum of Need
MOU Memoranda of Understanding
MNVP Medically Necessary Veterinary Product
NA Not Approvable
NADA New Animal Drug Application
NAFTA North American Free Trade Agreement
NAS New Active Substance
NCE New Chemical Entity
NCS Not Clinically Significant
NDA New Drug Application
NDS New Drug Study
NF National Formulary
NLEA Nutrition Labeling and Education Act
NME New Molecular ENtity
NSR Nonsignificant Risk
OAI Official Action Indicated
PD Pharmacodynamics
PDUFA Prescription Drug User Fee Act of 1992
PK Pharmacokinetics
PMA Premarket Approval
RCT Randomized Clinical Trial
RPM Regulatory Procedures Manual
RTF Refusal to file
SBA Summary Basis of Approval
SMDA Safe Medical Devices Act
SOPs Standard Operating Procedures
TRO Temporary Restraining Order
USAN United States Adopted Name
USCA U.S. Code Annotated
USP U.S. Pharmacopeia
VAERS Vaccine Adverse Event Reporting System
VAI Voluntary Action Indicated
VFD Veterinary Feed Directive
VMF Veterinary Master FIle

 

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