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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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The Drug Efficacy Study and Its Manifold Legacies

The Drug Efficacy Study and Its Manifold Legacies

Chapter:
(p.306) Chapter Sixteen The Drug Efficacy Study and Its Manifold Legacies
Source:
FDA in the Twenty-First Century
Author(s):

Daniel Carpenter

Jeremy Greene

Susan Moffitt

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231171182.003.0022

The Drug Efficacy Study Initiative decisively reshaped modern drug regulation. Our purpose in reviewing the development of the Drug Efficacy Study and its implementation is threefold: to demonstrate how the process of standardization emerged in FDA drug regulation and contributed to FDA’s power, to highlight the ways in which DESI and FDA’s process of standardization evoke long-standing debate on the impact of product regulation, and to suggest potential durable legacies DESI may have on pharmaceutical markets and public health.

Keywords:   Regulation, Standardization, DESI, FDA, pharmaceuticals

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