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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: 04 July 2022

Drug Safety Communication

Drug Safety Communication

The Evolving Environment

(p.328) Chapter Seventeen Drug Safety Communication
FDA in the Twenty-First Century

Geoffrey Levitt

Columbia University Press

Over the last decade, control over communications about the safety of medicines has shifted away from drug sponsors and regulators to a broader set of stakeholders including payors, academic researchers, and independent drug information centers. New governance rules around the quality of drug safety data and analyses and optimal communications methods are needed to ensure that drug safety information will continue to be disseminated in a way that optimizes prescribing decisions and supports the public health.

Keywords:   Drug safety, medical communications, benefit-risk profile, pharmacovigilance, drug safety reporting, clinical trial information

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