The Future of Drug Safety: Promoting and Protecting the Health of the Public (2007)
Chapter: Appendix B Acronyms
Appendix B
Acronyms
ADR adverse drug report
AE adverse event
AER adverse event review
AERS Adverse Event Reporting System
AHRQ Agency for Healthcare Research and Quality
BLA biologics license application
CBER Center for Biologics Evaluation and Research
CDC Centers for Disease Control and Prevention
CDER Center for Drug Evaluation and Research
CDRH Center for Devices and Radiological Health
CERTS Center for Education and Research Therapeutics
CFR Code of Federal Regulations
CFSAN Center for Food Safety and Applied Nutrition
CGMPs Current Good Manufacturing Practices
CMS Centers for Medicare and Medicaid Services
COPR Council of Public Representatives
CVM Center for Veterinary Medicine
DDMAC Division of Drug Marketing, Advertising and Communication
DDRE Division of Drug Risk Evaluation
DHHS Department of Health and Human Services
DSaRM Drug Safety and Risk Management Advisory Committee
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
OIG Office of Inspector General
OMB Office of Management and Budget
OMP Office of Medical Policy
OND Office of New Drugs
OP Office of Planning
OPaSS Office of Pharmacoepidemiology and Statistical Science
OSE Office of Surveillance and Epidemiology
PDUFA Prescription Drug User Fee Act
PLA product license application
RiskMAP risk minimization action plan
SRS Spontaneous Reporting System
UK United Kingdom
USDA US Department of Agriculture
VSD Vaccine Safety Datalink
WHO World Health Organization
