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Principles & Practice of Public Health Surveillance$
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Lisa M. Lee, Steven M. Teutsch, Stephen B. Thacker, and Michael E. St. Louis

Print publication date: 2010

Print ISBN-13: 9780195372922

Published to Oxford Scholarship Online: September 2010

DOI: 10.1093/acprof:oso/9780195372922.001.0001

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PRINTED FROM OXFORD SCHOLARSHIP ONLINE (oxford.universitypressscholarship.com). (c) Copyright Oxford University Press, 2020. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in OSO for personal use. date: 25 October 2020

PostMarket Surveillance of Medical Products in the United States

PostMarket Surveillance of Medical Products in the United States

(p.339) 16 PostMarket Surveillance of Medical Products in the United States
Principles & Practice of Public Health Surveillance

Paul J. Seligman

Thomas P. Gross

M. Miles Braun

Janet B. Arrowsmith

Oxford University Press

This chapter describes the application of specific principles to the practice of postmarket monitoring pharmaceutical products and medical devices. The purpose of postmarket surveillance is the identification of unanticipated adverse events (AEs) associated with medical product use; discovery of interaction not identified before market entry (patient-product, product-product, and product-environment); monitoring for unanticipated uses or misuses by prescribers or patients; and identification of failures due to manufacturing, design, labeling, packaging, or maintenance which occur after a medical product is marketed. In collaboration with manufacturers, healthcare providers, patients, consumers, and federal, state and local public health agencies, the US Food and Drug Administration monitors marketed medical products for AEs and product problems that occur after market entry. The chapter describes postmarket surveillance practices in the United States and how these practices influence the availability of and labeling for these products.

Keywords:   postmarket, pharmaceuticals, devices, Food and Drug Administration, FDA, medical products, safety, surveillance, public health

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