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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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After the FDA

After the FDA

A Twentieth-Century Agency in a Postmodern World

(p.76) Chapter Four After the FDA
FDA in the Twenty-First Century

Theodore W. Ruger

Columbia University Press

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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