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FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals
Date:6/15/2010

New website will contain safety reports on recently approved drugs, biologics

SILVER SPRING, Md., June 15 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration today unveiled a new source of information for patients and health care professionals on the safety of recently approved drugs and biologics.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Summaries of FDA safety analyses on recently approved products will now be periodically prepared and posted on FDA's website along with a brief discussion of the steps FDA is taking to address any identified safety issues.

Some side effects may not become apparent until after a medicine has been approved and becomes available to a larger, more diverse population than the patients who participated in clinical trials that supported approval. The new summaries provide a comprehensive look at safety data early in the product's post-approval life cycle and are based on reports by manufacturers, providers, consumers and others to the FDA's Adverse Event Reporting System (AERS) and the Vaccine Adverse Event Reporting System maintained by the FDA and the Center for Disease Control and Prevention; periodic safety information submitted to FDA by manufacturers; information contained in the medical literature; and data from ongoing drug and biologic studies.

Included in the summaries may be information on potentially serious, previously unidentified risks, if any are found during the review, as well as known adverse even
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SOURCE U.S. Food and Drug Administration
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