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Building a National Framework for the Establishment of Regulatory Science for Drug Development : Workshop Summary - Board on Health Sciences Policy

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

Workshop Summary

Paperback Published: 15th February 2011
ISBN: 9780309158893
Number Of Pages: 94

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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.

1 Front Matter; 2 1 Introduction; 3 2 Defining Regulatory Science; 4 3 The Urgent Need for Regulatory Science; 5 4 Barriers to Enhanced Regulatory Science; 6 5 Potential Models for Building a Regulatory Science Infrastructure; 7 6 Challenges in Engaging the Public Policy Community; 8 7 Envisioning Successful Regulatory Science at FDA; 9 8 Considering Next Steps; 10 References; 11 Appendix A: Agenda; 12 Appendix B: Participant Biographies

ISBN: 9780309158893
ISBN-10: 0309158893
Audience: Professional
Format: Paperback
Language: English
Number Of Pages: 94
Published: 15th February 2011
Publisher: National Academies Press
Country of Publication: US
Dimensions (cm): 22.9 x 15.2  x 0.64
Weight (kg): 0.16

Earn 134 Qantas Points
on this Book