Jump to ContentJump to Main Navigation
FDA in the Twenty-First CenturyThe Challenges of Regulating Drugs and New Technologies$
Users without a subscription are not able to see the full content.

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

Show Summary Details
Page of

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: 13 June 2021

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

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

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

Howard Sklamberg

Jennifer Devine

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231171182.003.0004

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

Columbia Scholarship Online requires a subscription or purchase to access the full text of books within the service. Public users can however freely search the site and view the abstracts and keywords for each book and chapter.

Please, subscribe or login to access full text content.

If you think you should have access to this title, please contact your librarian.

To troubleshoot, please check our FAQs, and if you can't find the answer there, please contact us .