Title Challenges for the FDA : the Future of Drug Safety : Workshop Summary / 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

Published Washington, DC : National Academies Press, ©2007

Click on the following:
ProQuest Ebook Central

Copies

Description 1 online resource (xvii, 109 pages) : illustrations Series Online access: NCBI NCBI Bookshelf Contents 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 Bibliography Includes bibliographical references (pages 78-79) Notes English Print version record Subject United States. Food and Drug Administration -- Rules and practice SUBJECT United States Food and Drug Administration -- rules & practice United States Food and Drug Administration United States. Food and Drug Administration. fast (OCoLC)fst00549734 Subject Drugs -- United States -- Testing -- Congresses Drugs -- United States -- Safety measures -- Congresses Drugs -- Side effects. Pharmacovigilance. Drugs -- Side effects -- Reporting. Drug monitoring. Drug interactions. Drug-Related Side Effects and Adverse Reactions -- prevention & control United States Food and Drug Administration Drug Approval -- organization & administration Drug-Related Side Effects and Adverse Reactions Drug Approval Safety Pharmacovigilance Drug Monitoring Drug Combinations Product Surveillance, Postmarketing Product Surveillance, Postmarketing -- standards Adverse Drug Reaction Reporting Systems -- organization & administration Drug Evaluation, Preclinical -- standards Drug Interactions Government Agencies MEDICAL -- Drug Guides. MEDICAL -- Pharmacology. MEDICAL -- Pharmacy. MEDICAL -- Nursing -- Pharmacology. Pharmacovigilance. Drugs -- Side effects -- Reporting. Drugs -- Side effects. Drug monitoring. Drug interactions. Drugs -- Safety measures. Drugs -- Testing. SUBJECT United States Subject United States. Genre/Form Conference papers and proceedings. Rules. Conference papers and proceedings. Actes de congrès. Form Electronic book Author Pray, Leslie A. Robinson, Sally. Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation. ISBN 9780309109871 0309109876 1281093556 9781281093554 9786611093556 6611093559 0309179440 9780309179447

  Permalink