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Professional NewsFull Access

FDA Creates Web Site On Drug Safety Info

Published Online:https://doi.org/10.1176/pn.43.23.0034c

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. ▪