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

Workshop Summary

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

Anne B. Claiborne, Rebecca A. English (Herausgeber)

Buch | Hardcover

94 Seiten

2011
National Academies Press (Verlag)
978-0-309-38348-6 (ISBN)

Infos

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.

Table of Contents


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

Inhalt

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

Produkt-Details

• Verlagsort: Washington
• Sprache: englisch
• Maße: 152 x 229 mm
• Themenwelt: Studium ► Querschnittsbereiche ► Prävention / Gesundheitsförderung
• ISBN-10: 0-309-38348-X / 030938348X
• ISBN-13: 978-0-309-38348-6 / 9780309383486
• Zustand: Neuware