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

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

Workshop Summary

,
  1. English
  2. ePUB (mobile friendly)
  3. Available on iOS & Android
eBook - ePub

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

Workshop Summary

,

About this book

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.

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Edition
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Table of contents

  1. COVER PAGE
  2. THE NATIONAL ACADEMIES
  3. FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION1
  4. Reviewers
  5. Contents
  6. Figures and Boxes
  7. Acronyms
  8. Preface
  9. 1 Introduction
  10. 2 Defining Regulatory Science
  11. 3 The Urgent Need for Regulatory Science
  12. 4 Barriers to Enhanced Regulatory Science
  13. 5 Potential Models for Building a Regulatory Science Infrastructure
  14. 6 Challenges in Engaging the Public Policy Community
  15. 7 Envisioning Successful Regulatory Science at FDA
  16. 8 Considering Next Steps
  17. References
  18. Appendix A Agenda
  19. Appendix B Participant Biographies