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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: 17 May 2022

FDA’s Public Health Imperative

FDA’s Public Health Imperative

An Increased Role for Active Postmarket Analysis

(p.286) Chapter Fifteen FDA’s Public Health Imperative
FDA in the Twenty-First Century

Efthimios Parasidis

Columbia University Press

This chapter focuses on current and emerging issues related to post-market analysis of medical products. It argues that the future of the FDA as a public health agency is largely dependent on how well the agency leverages its mandate and resources to address the limitations of pre-market review and expand the instances in which post-market analysis is required.

Keywords:   FDA, Post-market surveillance, Sentinel System, Public Health, Big Data

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