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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

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

Daniel Carpenter

Jeremy Greene

Susan Moffitt

Columbia University Press

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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