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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, 2021. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in CUPSO for personal use.date: 29 July 2021

Race and the FDA

Race and the FDA

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

Jonathan Kahn

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231171182.003.0035

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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