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FDA in the Twenty-First CenturyThe Challenges of Regulating Drugs and New Technologies$
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Holly Fernandez Lynch and I. Glenn Cohen

Print publication date: 2015

Print ISBN-13: 9780231171182

Published to Columbia Scholarship Online: May 2016

DOI: 10.7312/columbia/9780231171182.001.0001

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PRINTED FROM COLUMBIA SCHOLARSHIP ONLINE (www.columbia.universitypressscholarship.com). (c) Copyright University of Minnesota Press, 2022. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in CUPSO for personal use.date: 19 May 2022

Speed Versus Safety in Drug Development

Speed Versus Safety in Drug Development

(p.251) Chapter Thirteen Speed Versus Safety in Drug Development
FDA in the Twenty-First Century

R. Alta Charo

Columbia University Press

Enhancing postmarket surveillance and controls can improve drug safety and permit faster “conditional” approvals on somewhat less robust data. But this will not work unless premarket R&D investment is at least partially delinked from the promise of largely unconstrained postmarket monopoly markets.

Keywords:   conditional approval, postmarket surveillance, REMS, Sentinel, Speed, safety

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