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510K | Premarket notification (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 |
APHIS | Animal Plant and Health Inspection Service (USDA) |
BLA | Biologics License Application |
BIMO | Bioresearch Monitoring |
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 |
CFO | Chief Financial Officer |
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 |
COBOL | Common Business Oriented Language |
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 |
FFD&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 Equivalent |
FY | Fiscal Year (October – September) |
GAO | General 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 |
IVD | In Vitro Diagnostic |
JECFA | Joint Expert Committee on Food Additives |
JIFSAN | Joint Institute for Food Safety and Applied Nutrition |
JINAD | Generic Investigational New Animal Drug |
LACF | Low Acid Canned Foods |
LAN | Local Area Network |
LBITF | Least Burdensome Industry Task Force |
MATS | Management Assignment Tracking System |
MDR |
Medical Device Reporting System |
MERS-TM | Medical Event Reporting System for Transfusion Medicine |
MMBM | Mammalian Meat and Bone Meal |
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 |
NPRM | Notice of Proposed Rulemaking |
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 (CBER) |
OPA | Office of Premarket Approvals (CFSAN) |
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) |
OTRR | Office of Therapeutics Research and Review (CBER) |
OVRR | Office of Vaccines Research and Review (CBER) |
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 (CBER) |
RMS-BLA | Regulatory Management System-Biologics License Application |
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 Tphimurium DT 104 |
TB | Tuberculosis |
TRIMS | Tissue Residue Information System |
UK | United Kingdom |
UMCP | University of Maryland-College Park |
USDA | United 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 |
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