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FDA Announces Adverse-Event Website

June 17, 2010
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The U.S. Food and Drug Administration (FDA) has unveiled a new website that will serve as a source of information for patients and health care professionals on the safety of recently approved drugs and biologics.

Summaries of FDA safety analyses on recently approved products will now be periodically prepared and posted on the website. 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 events that occur more often than they did during clinical studies. The summaries will also include a brief discussion of any steps FDA may be taking to address these safety issues.

Under Section 915 of the Food and Drug Administration Amendments Act of 2007, FDA is required to prepare safety summaries within 18 month after a product’s approval or after it has been used by 10,000 patients, whichever comes later.

Initial summary reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, depression and other conditions.

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