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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

The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007

The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007

Chapter:
(p.92) Chapter Five The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007
Source:
FDA in the Twenty-First Century
Author(s):

Barbara J. Evans

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231171182.003.0007

This chapter explores special challenges FDA will face when assessing the safety and effectiveness of 21st-century preventive medical products that aim to avert future disease (as opposed to treating manifest disease). The Food and Drug Administration Amendments Act of 2007 gave the agency important new powers to address these challenges but, to date, the agency has not yet fully tapped these new powers.

Keywords:   predictive medicine, personalized medicine, precision medicine, preventive medicine, FDAAA, Section 505(o)(3)

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