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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Main Author: Lebovitz, Yeonwoo
Corporate Author: Institute of Medicine (U.S.) Forum on Drug Discovery, Development, and Translation
Other Authors: English, Rebecca A., Claiborne, Anne B.
Format: eBook
Published: Washington, D.C. National Academies Press c2011, 2011
Online Access:
Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
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
  • Includes bibliographical references