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Suggested Citation:"Appendix B Acronyms." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
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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

Suggested Citation:"Appendix B Acronyms." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

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

Suggested Citation:"Appendix B Acronyms." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

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

Suggested Citation:"Appendix B Acronyms." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
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Suggested Citation:"Appendix B Acronyms." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
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Suggested Citation:"Appendix B Acronyms." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
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Suggested Citation:"Appendix B Acronyms." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
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Page 219
Suggested Citation:"Appendix B Acronyms." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
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Page 220
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In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' risk–benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.

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