Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies ; Leslie Pray and Sally Robinson, rapporteurs.
Includes bibliographical references (pages 78-79).
Addressing the FDA's Resource Challenges -- Strengthening the Scientific Base of the Agency -- Integrating Pre- and Postmarket Review -- Enhancing Postmarket Safety Monitoring -- Conducting Confirmatory Drug Safety and Efficacy Studies -- Enhancing the Value of Clinical Trial Registration -- Enhancing Postmarket Regulation and Enforcement -- Looking to the Future.
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Challenges for the FDA.
9780309109864
United States.-- Rules and practice.
United States
United States-- rules & practice
United States.
Drugs-- United States-- Safety measures, Congresses.
Drugs-- United States-- Testing, Congresses.
Adverse Drug Reaction Reporting Systems-- organization & administration.
Drug Approval-- organization & administration.
Drug Approval.
Drug Approval.
Drug Evaluation, Preclinical-- standards.
Drug Interactions.
Drug-Related Side Effects and Adverse Reactions-- prevention & control.
Drug-Related Side Effects and Adverse Reactions.
Drug-Related Side Effects and Adverse Reactions.
Government Agencies.
Product Surveillance, Postmarketing-- standards.
Product Surveillance, Postmarketing.
Safety.
United States Food and Drug Administration
Drugs-- Safety measures.
Drugs-- Testing.
MEDICAL-- Drug Guides.
MEDICAL-- Nursing-- Pharmacology.
MEDICAL-- Pharmacology.
MEDICAL-- Pharmacy.
United States.
United States.
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S9889c
2007
Pray, Leslie A.
Robinson, Sally.
Symposium on the Future of Drug Safety: Challenges for the FDA(2007 :, Washington, D.C.)
Institute of Medicine (U.S.)., Forum on Drug Discovery, Development, and Translation.