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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

Twenty-First-Century Technology with Twentieth-Century Baggage

Twenty-First-Century Technology with Twentieth-Century Baggage

FDA Regulation of Regenerative Medicine

Chapter:
(p.455) Chapter Twenty-Four Twenty-First-Century Technology with Twentieth-Century Baggage
Source:
FDA in the Twenty-First Century
Author(s):

Margaret Foster Riley

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231171182.003.0032

FDA has successfully defended its regulatory rubric that requires treatments using more than minimally manipulated cells to be approved as drugs. Going forward, it will need clearer standards and regulatory flexibility to support the development of regenerative medicine.

Keywords:   Stem cells, Practice of medicine, Cell therapy

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