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Title:

Building a national framework for the establishment of regulatory science for drug development : workshop summary / Yeonwoo Lebovitz, Rebecca A. English and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies.

Publisher:

National Academies Press,

Copyright Date:

c2011

Description:

xvi, 78 p. : col. ill. ; 23 cm.

Subject:

United States.--Food and Drug Administration.
Drug development--United States--Congresses.

Other Authors:

Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation
Lebovitz, Yeonwoo
English, Rebecca A.
Claiborne, Anne B.

Notes:

Includes bibliographical references.

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.

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 examine the state of regulatory science and to consider approaches for enhancing it."--Publisher's description.

ISBN:

9780309158893
0309158893

OCLC:

(OCoLC)681488332

Locations:

USUX851 -- Iowa State University - Parks Library (Ames)

OVUX522 -- University of Iowa Libraries (Iowa City)