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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

Race and the FDA

Race and the FDA

(p.501) Chapter Twenty-Seven Race and the FDA
FDA in the Twenty-First Century

Jonathan Kahn

Columbia University Press

The FDA has played a prominent role in efforts to harmonize international regulatory schemes for pharmaceutical review and approval, including the promulgation of guidelines on the use of racial and ethnic categories in pharmaceutical development. These guidelines, while well-intentioned, may be having the unintended consequence of reifying race as genetic.

Keywords:   FDA, International Conference on Harmonization, Race, Ethnicity, Harmonization, Genetics

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