Building a National Framework for the Establishment of Regulatory Science for Drug Development:

Workshop Summary

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Size: 94 pages, 6 x 9

Publication Year:2011

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PAPERBACK ISBN-10: 0-309-15889-3 ISBN-13: 978-0-309-15889-3	$21.00	Add to Cart

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Authors:
Yeonwoo Lebovitz, Rebecca English, and Anne Claiborne; Forum on Drug Discovery, Development, and Translation; Institute of Medicine
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Table of Contents
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Front Matter	i-xvi
1 Introduction	1-4	(skim)
2 Defining Regulatory Science	5-12	(skim)
3 The Urgent Need for Regulatory Science	13-22	(skim)
4 Barriers to Enhanced Regulatory Science	23-30	(skim)
5 Potential Models for Building a Regulatory Science Infrastructure	31-38	(skim)
6 Challenges in Engaging the Public Policy Community	39-44	(skim)
7 Envisioning Successful Regulatory Science at FDA	45-48	(skim)
8 Considering Next Steps	49-52	(skim)
References	53-56	(skim)
Appendix A: Agenda	57-60	(skim)
Appendix B: Participant Biographies	61-78	(skim)

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The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it.

Building a National Framework for the Establishment of Regulatory Science for Drug Development:

Workshop Summary

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