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Introducing MEDWatch

Introducing MEDWatch UNFORTUNATELY, many health professionals do not think to report adverse events that might be associated with medications or devices to the Food and Drug Administration (FDA) or to the manufacturer. That needs to change, and the FDA is taking steps to encourage that to happen. Reports from health professionals of adverse events or product quality problems are essential to ensure the safety of drugs, biologicals, medical devices, and other products regulated by the FDA once they are introduced into the US market. Even the large, well-designed clinical trials that are conducted to gain pre-market approval cannot uncover every problem that can come to light once a product is widely used. A new drug application, for example, typically includes safety data on several hundred to several thousand patients. If an adverse event occurs in perhaps one in 5000 or even one in 1000 users, it could be missed in clinical trials http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Introducing MEDWatch

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Publisher
American Medical Association
Copyright
Copyright © 1993 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.1993.03500210065033
Publisher site
See Article on Publisher Site

Abstract

UNFORTUNATELY, many health professionals do not think to report adverse events that might be associated with medications or devices to the Food and Drug Administration (FDA) or to the manufacturer. That needs to change, and the FDA is taking steps to encourage that to happen. Reports from health professionals of adverse events or product quality problems are essential to ensure the safety of drugs, biologicals, medical devices, and other products regulated by the FDA once they are introduced into the US market. Even the large, well-designed clinical trials that are conducted to gain pre-market approval cannot uncover every problem that can come to light once a product is widely used. A new drug application, for example, typically includes safety data on several hundred to several thousand patients. If an adverse event occurs in perhaps one in 5000 or even one in 1000 users, it could be missed in clinical trials

Journal

JAMA – American Medical Association

Published: Jun 2, 1993

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