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

ts 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 (FDAAA), FDA is required to prepare the safety summaries within 18 months after a product's approval or after it has been used by 10,000 patients, whichever comes later.

"Conducting systematic, comprehensive, safety reviews of recently approved drugs and biologics provides an early detection mechanism for potentially serious risks and complements the FDA's analysis of safety data during drug development and the agency's routine monitoring of safety information after product approval," said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology in the FDA's Center for Drug Evaluation and Research.

"These summaries will provide clear and useful information in a timely manner that can be used by providers and patients to make informed decisions about an individual's health," said Robert Ball, M.D., M.P.H., Sc.M., director of the Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research.

Initial summary reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, depression and other conditions. The summary reports will be located on an FDA Web page that was first established in 2008 to serve as a portal for drug safety information.

For more information

Postmarketing Drug Safety Evaluation


SOURCE U.S. Food and Drug Administration
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