510(k) Premarket notification for medical devices substantially equivalent to products already on the market
AADA Abbreviated Antibiotic Drug Application
ADE Adverse Drug Event
ADAA Animal Drug Availability Act of 1996
ADR Adverse Drug Report
AERS Adverse Events Reporting System
AHI Animal Health Institute
AIDS Acquired Immune Deficiency Syndrome
ANDA Abbreviated New Drug Application
ANSI American National Standards Institute
BLA Biologic License Application
BIMO Bioresearch Monitoring System
BRMS Biologics Regulatory Management System
BSE Bovine Spongiform Encephalopathy (Mad Cow Disease)
CABS Conformity Assessment Bodies
CARS Compliance Achievement Reporting System
CBER FDA Center for Biologics Evaluation and Research
CDC Centers for Disease Control and Prevention
CDER FDA Center for Drug Evaluation and Research
CDRH FDA Center for Devices and Radiological Health
CFSAN FDA Center for Food Safety and Applied Nutrition
CGMPs Current Good Manufacturing Practices
CJD Creutzfeldt-Jakob disease
CMC Chemistry, Manufacturing, and Controls
COMSTAT Compliance Status Information System
CRADA Cooperative Research and Development Agreement
CRS Contamination Response System
CTS Correspondence Tracking System
CVM FDA Center for Veterinary Medicine
DHHS Department of Health and Human Services
DNA Deoxyribonucleic acid
DOD Department of Defense
DoL Department of Labor
DQRS Drug Quality Reporting System
DRLS Drug Registration and Listing System
DSHEA Dietary Supplement Health and Education Act
EDR Electronic Document Room
EDMS Electronic Data Management System
EIP Emerging Infection Program
EIR Establishment Inspection Report
ELA Establishment License Application
EPA Environmental Protection Agency
ERS Economic Research Service
ETS Environmental Tobacco Smoke
EU European Union
FACTS Field Accomplishment and Compliance Tracking System
FAO United Nations Food and Agricultural Organization
FAS USDA Foreign Agriculture Service
FDAMA Food and Drug Administration Modernization Act of 1997
FD&C Act Federal Food, Drug and Cosmetic Act
FIS Field Information System
FLQ Fluoroquinolone
FORCG Food Outbreak Coordination Response Group
FPL Final Printed Label
FPLA Fair Packaging and Labeling Act
FSI National Food Safety Initiative
FSIS Food Safety Inspection Service (USDA)
FTC Federal Trade Commission
FTE Full-time equivalents
FY Fiscal Year (October – September)
GAO Government Accounting Office
GAPs Good Agricultural Practices
GATT General Agreement on Tariffs and Trade
GPRA Government Performance and Results Act of 1993
GMPs Good Manufacturing Practices
GRAS Generally Recognized as Safe food ingredients
GSFA General Standards for Food Additives
HACCP Hazard Analysis Critical Control Points (a quality assurance and inspection technique)
HDE Humanitarian Device Exemption
HIV Human Immunodeficiency Virus
HUD Humanitarian Use Device
ICH International Conference on Harmonization
IDE Investigational Device Exemption
INAD Investigational New Animal Drug
INADA Investigational New Animal Drug Application
IND Investigational New Drug
IOM Institute of Medicine
ISO International Standards Organization
ISRS Individual Safety Reports
IT Information technology
JIFSAN Joint Institute for Food Safety and Applied Nutrition
LACF Low Acid Canned Foods
LAN Local Area Network
MATS Management Assignment Tracking System
MDR Medical Device Reporting system
MOU Memorandum of Understanding
MPRIS Mammography Program Reporting and Information Systems
MQSA Mammography Quality Standards Act
MRA Mutual Recognition Agreement
NADA New Animal Drug Application
NAFTA North Atlantic Free Trade Agreement
NAFTA TWG North American Free Trade Agreement Technical Working Group
NARMS National Antimicrobial Resistance Monitoring System
NASS National Agricultural Statistics Survey
NCI National Cancer Institute
NCIE Notice of Claimed Investigational Exemptions
NCTR FDA National Center for Toxicological Research
NDA New Drug Application
NDE/MIS New Drug Evaluation Management Information System
NIAID National Institute of Allergy and Infectious Diseases
NIDA National Institute on Drug Abuse
NIEHS National Institute for Environmental Health Sciences
NIH National Institute of Health
NLEA Nutrition Labeling and Education Act
NME New Molecular Entity
NPR National Partnership for Reinventing Government
NRC National Research Council
NTP National Toxicology Program
NVPO National Vaccine Program Office
OASIS Operational and Administrative System for Import Support
OBRR Office of Blood Research and Review
OPA CFSAN, Office of Premarket Approvals
ORA FDA Office of Regulatory Affairs
ORISE Oak Ridge Institute for Science and Education
OSHA Occupational Safety and Health Administration
OTC Over-the-counter
OTR Office of Testing and Research (CDER)
PAS FDA Public Affairs Specialist
PDPs Product Development Protocols
PDUFA Prescription Drug User Fee Act of 1992
PIFSI Produce and Food Safety Initiative
PLA Product License Application
PMA Premarket Approval (Application to market medical device that requires premarket approval)
PODS Project-Oriented Data System
PQRI Product Quality Research Initiative
QSIT Quality System Inspection Technique
RA Rheumatoid Arthritis
RCHSA Radiation Control for Health and Safety Act
REGO Reinventing government initiative
RIMS Regulatory Information Management Staff
RVIS Residue Violation Information System
SAB Science Advisory Board
SAMHSA Substance Abuse and Mental Health Services Administration
SE Salmonella Enteriditis
SN/AEMS Special Nutritional Adverse Events Monitoring System
STARS Submission Tracking and Review System
StmDT104 Salmonella typhimurium DT 104
TB Tuberculosis
TRIMS Tissue Residue Information System
UK United Kingdom
UMCP University of Maryland-College Park
USDA Unites States Department of Agriculture
VAERS Vaccine Adverse Event Reporting System
VFD Veterinary Feed Directive
VICH Veterinary International Conference on Harmonization
WHO United Nations World Health Organization
WTO World Trade Organization
Edited 3/1/2000