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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: 05 August 2021

After the FDA

After the FDA

A Twentieth-Century Agency in a Postmodern World

Chapter:
(p.76) Chapter Four After the FDA
Source:
FDA in the Twenty-First Century
Author(s):

Theodore W. Ruger

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231171182.003.0006

The FDA over the past century has achieved high levels of regulatory prestige by enforcing statutory standards of safety and efficacy with relatively little regulation of the end-stage use, or the ultimate price, of food and drugs. This traditional regulatory model is under strain in the twenty-first century as new resource constraints and concerns over consumer and physician behavior increase, and the FDA will need to adapt its regulatory focus to remain relevant.

Keywords:   FDA, Pharmaceuticals, Food, Regulation, cost-effectiveness, comparative-effectiveness

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