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Published Online: 5 December 2008

FDA Creates Web Site On Drug Safety Info

Health care professionals and the public can now go to a single page on the Food and Drug Administration's Web site to find a variety of safety information about prescription drugs. The Web page at<www.fda.gov/cder/drugSafety.htm> provides links to the following topics and more:
Drug labeling, including patient labeling, professional labeling, and patient package inserts
Drugs with a Risk Evaluation and Mitigation Strategy (REMS) for weighing benefits against risks
A database of postmarket studies
Clinicaltrials.gov
Warning letters, recalls, market withdrawals, and safety alerts.
Instructions on how to report problems to the FDA through its MedWatch program
Establishing such a Web page is one of the requirements of the Food and Drug Administration Amendments Act of 2007. ▪

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Published online: 5 December 2008
Published in print: December 5, 2008

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