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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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Bibliographic Details
Online Access: Full Text (via ProQuest)
Corporate Authors: Symposium on the Future of Drug Safety: Challenges for the FDA Washington, D.C., Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation
Other Authors: Pray, Leslie A., Robinson, Sally
Format: Conference Proceeding eBook
Language:English
Published: Washington, DC : National Academies Press, ©2007.
Series:Online access: NCBI NCBI Bookshelf.
Subjects:
United States. > Food and Drug Administration > Rules and practice.
Drugs > United States > Testing > Congresses.
Drugs > United States > Safety measures > Congresses.
Drugs > Side effects.
Pharmacovigilance.
Drugs > Side effects > Reporting.
Drug monitoring.
Drug interactions.
United States. > Food and Drug Administration.
Drugs > Safety measures.
Drugs > Testing.
United States.
Conference papers and proceedings.
Rules.
Table of 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.

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