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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

Overcoming “Premarket Syndrome”

Overcoming “Premarket Syndrome”

Promoting Better Postmarket Surveillance in an Evolving Drug-Development Context

(p.268) Chapter Fourteen Overcoming “Premarket Syndrome”
FDA in the Twenty-First Century

Shannon Gibson

Trudo Lemmens

Columbia University Press

This chapter explores both the promises and risks associated with rising interest in niche market drug development and concurrently, how drug regulatory reform efforts towards the “lifecycle” approach and more post-market evidence generation are both a response to and a driving force behind the shift towards niche markets. We argue that significant questions remain about whether regulatory authorities are prepared to address the attendant challenges that accompany the shift towards the lifecycle approach, particularly the concern that increasing the focus on post-market monitoring and evaluation may lead to a softening of regulatory control at market entry.

Keywords:   Niche markets, pharmaceutical regulation, regulatory reform, conditional approval, lifecycle approach, pharmacogenomics

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