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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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Speed Versus Safety in Drug Development

Speed Versus Safety in Drug Development

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

R. Alta Charo

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231171182.003.0018

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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