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



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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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

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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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

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