DSB Drug Safety Oversight Board

DTCA direct-to-consumer advertising

ELA established license application

EMEA European Medicines Agency

EU European Union

FAA Federal Aviation Administration

FDA Food and Drug Administration

FDAMA Food and Drug Administration Modernization Act of 1997

FD&C Act Federal Food, Drug, and Cosmetic Act

FOIA Freedom of Information Act

FTC Federal Trade Commission

FTE full-time equivalent

FY fiscal year

GAO Government Accountability Office

GGP good guidance practice

GLP good laboratory practice

GMP good manufacturing practice

GPRD General Practice Research Database

GRMP good review manufacturing practice

HIPAA Health Insurance Portability and Accountability Act

IND Investigational New Drug

IOM Institute of Medicine

IRB institutional review board

IT information technology

MaPP Manual of Policies and Procedures

MHRA Medicines and Healthcare Products Regulatory Agency

NAS National Academy of Sciences

NASA National Aeronautics and Space Administration

NCTR National Center for Toxicological Research

NDA New Drug Application

NIH National Institutes of Health

NME new molecular entity

NSAID non-steroidal anti-inflammatory drug

ODE Office of Drug Evaluation

ODS Office of Drug Safety

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