Challenges for the FDA:

The Future of Drug Safety, Workshop Summary

Status: Available Now

Size: 128 pages, 6x9

Publication Year:2007

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PAPERBACK ISBN-10: 0-309-10986-8 ISBN-13: 978-0-309-10986-4	$32.00	Add to Cart

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Authors:
Leslie Pray and Sally Robinson, Rapporteurs, Forum on Drug Discovery, Development, and Translation
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Table of Contents
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Front Matter	i-xviii
Summary	1-8	(skim)
1 Introduction	9-12	(skim)
2 Addressing the FDA's Resource Challenges	13-18	(skim)
3 Strengthening the Scientific Base of the Agency	19-25	(skim)
4 Integrating Pre- and Postmarket Review	26-31	(skim)
5 Enhancing Postmarket Safety Monitoring	32-48	(skim)
6 Conducting Confirmatory Drug Safety and Efficacy Studies	49-53	(skim)
7 Enhancing the Value of Clinical Trial Registration	54-57	(skim)
8 Enhancing Postmarket Regulation and Enforcement	58-69	(skim)
9 Looking to the Future	70-77	(skim)
References	78-80	(skim)
Appendix A Workshop Agenda	81-92	(skim)
Appendix B Speaker Biographies	93-110	(skim)

Challenges for the FDA:

The Future of Drug Safety, Workshop Summary

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