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FDA to publicise new drug safety info

The US Food and Drug Administration has created a new website intended to provide more information about the safety of recently launched drugs

The US Food and Drug Administration (FDA) has created a new website intended to provide healthcare professionals and the general public with more information about the safety of recently launched drugs and biologics.

"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 FDA said in explaining the rationale for the site.

Federal regulations already require the FDA to prepare safety summaries within 18 months after a product's approval or after it has been used by 10,000 patients, whichever comes later, but those summaries have not until now been easily accessible by the public.

The new website will include summaries of FDA safety analyses on the products; reports to the FDA's Adverse Event Reporting System and the Vaccine Adverse Event Reporting System; periodic safety information submitted to FDA by manufacturers; information contained in the medical literature; and data from ongoing drug and biologic studies.

The summaries, which will be updated periodically, may include information on potentially serious, previously unidentified risks, as well as previously identified adverse events that turn out to occur more often than they did during clinical studies. In addition, the site will offer information regarding the steps FDA is taking to address any identified safety issues.

At launch, the site will contain summary reports on drugs and biologics approved since September 2007.

17th June 2010

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