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

Workshop Summary

Board on Health Sciences Policy, Development Forum on Drug Discovery and Translation, Institute of Medicine (Autoren)

Yeonwoo Lebovitz, Rebecca English (Herausgeber)

Buch | Softcover

94 Seiten

2011
National Academies Press (Verlag)
978-0-309-15889-3 (ISBN)

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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

Zusatzinfo	Illustrations
Verlagsort	Washington
Sprache	englisch
Maße	152 x 229 mm
Themenwelt	Medizin / Pharmazie
ISBN-10	0-309-15889-3 / 0309158893
ISBN-13	978-0-309-15889-3 / 9780309158893
Zustand	Neuware