Building a national framework for the establishment of regulatory science for drug development : workshop summary / Regulatory science for drug development

Building a national framework for the establishment of regulatory science for drug development : workshop summary /

"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 ex...

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Bibliographic Details
Corporate Author: Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation
Other Authors: Lebovitz, Yeonwoo, English, Rebecca A., Claiborne, Anne B.
Format: Electronic eBook
Language:English
Published: Washington, D.C. : National Academies Press, ©2011.
Subjects:
United States. > Food and Drug Administration.
Drug development > United States > Congresses.
Drug Discovery
Clinical Trials as Topic
Drug Approval
Drug Evaluation
United States
Congress
Conference papers and proceedings.
Online Access: Full text (Emmanuel users only)
Table of Contents:
  • Introduction
  • Defining regulatory sciences
  • The urgent need for regulatory science
  • Barriers to enhanced regulatory science
  • Potential models for building a regulatory science infrastructure
  • Challenges in engaging the public policy community
  • Envisioning successsful regulatory science at FDA
  • Considering next steps.

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