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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, 2022. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in CUPSO for personal use.date: 19 May 2022

A Global and Innovative Regulatory Environment for the U.S. FDA

A Global and Innovative Regulatory Environment for the U.S. FDA

(p.39) Chapter Two A Global and Innovative Regulatory Environment for the U.S. FDA
FDA in the Twenty-First Century

Howard Sklamberg

Jennifer Devine

Columbia University Press

This chapter offers an insider’s view from within FDA, focusing on the way in which the supply chain for therapeutics has become globalized, thrusting FDA into a new world of regulatory challenges. After describing this phenomenon, the chapter turns to how FDA has tried to manage these developments, including through congressional changes to agency authority, partnerships with other national regulators, and additional steps.

Keywords:   Globalization, International, supply chain, risk management, Global Regulatory Operations and Policy Directorate, harmonization

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