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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.

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Subject: United States. Food and Drug Administration > Rules and practice.
United States. Food and Drug Administration.
Drugs > United States > Testing > Congresses.
Drugs > United States > Safety measures > Congresses.
Drug Approval.
Product Surveillance, Postmarketing.
Drug-Related Side Effects and Adverse Reactions.
United States.
Genre: Electronic books.
Electronic books.

Record details

  • ISBN: 9780309109871
  • ISBN: 0309109876
  • ISBN: 1281093556
  • ISBN: 9781281093554
  • Physical Description: 1 online resource (xvii, 109 pages) : illustrations
  • Publisher: Washington, DC : National Academies Press, ©2007.

Content descriptions

Bibliography, etc. Note: Includes bibliographical references (pages 78-79).
Formatted Contents Note: 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.
Language Note: English.
Source of Description Note: Print version record.
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