Challenges for the FDA : the future of drug safety : workshop summary

Challenges for the FDA the future of drug safety : workshop summary

Bibliographic Details
Main Author: Symposium on the Future of Drug Safety: Challenges for the FDA (corporate author, -)
Corporate Authors: Symposium on the Future of Drug Safety: Challenges for the FDA Corporate Author (corporate author), Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation
Other Authors: Pray, Leslie A. (-), Robinson, Sally
Format: eBook
Language:Inglés
Published: Washington, DC : National Academies Press c2007.
Edition:1st ed
Subjects:
United States. > Food and Drug Administration > Rules and practice.
Drugs > United States > Testing > Congresses.
Drugs > United States > Safety measures > Congresses.
See on Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009622157506719
Table of Contents:
  • FrontMatter
  • Reviewers
  • Preface
  • Contents
  • Tables, Figures, and Boxes
  • Summary
  • 1 Introduction
  • 2 Addressing the FDA's Resource Challenges
  • 3 Strengthening the Scientific Base of the Agency
  • 4 Integrating Pre- and Postmarket Review
  • 5 Enhancing Postmarket Safety Monitoring
  • 6 Conducting Confirmatory Drug Safety and Efficacy Studies
  • 7 Enhancing the Value of Clinical Trial Registration
  • 8 Enhancing Postmarket Regulation and Enforcement
  • 9 Looking to the Future
  • References
  • Appendixes
  • Appendix A Workshop Agenda
  • Appendix B Speaker Biographies.

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