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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

Historical Themes and Developments at FDA Over the Past Fifty Years

Historical Themes and Developments at FDA Over the Past Fifty Years

Chapter:
(p.17) Chapter One Historical Themes and Developments at FDA Over the Past Fifty Years
Source:
FDA in the Twenty-First Century
Author(s):

Peter Barton Hutt

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231171182.003.0002

This chapter provides an overview of FDA’s history as a regulatory institution that now touches products comprising twenty-five cents out of every dollar spent by U.S. consumers, outlining agency management, rulemaking, use of guidance documents, enforcement, the birth and impact of user fees, and more.

Keywords:   FDA, Management, Rulemaking, Guidance, Enforcement, user fees

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