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FDA unveils new safety monitoring communication system
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The FDA unveiled a new source of information on the safety of recently approved drugs and biologics that will provide comprehensive insight into safety data early on during the product’s post-approval life cycle.
Under Section 915 of the FDA Amendments Act of 2007, the FDA is required to prepare safety summaries within 18 months after approval of a product or after it has been used by 10,000 patients — whichever comes later.
FDA officials will gather data from reports by manufacturers, providers, consumers and others sent to the FDA’s Adverse Event Reporting System, Vaccine Adverse Event Reporting System and safety information submitted to the FDA by manufacturers, information contained in the medical literature and data from ongoing drug and biologic studies.
Summaries of FDA safety reviews on recently approved products will be prepared and posted on FDA’s Web site along with a brief discussion of the steps FDA is taking to address any identified safety issues.
These summaries will include information on potentially serious, previously unidentified risks found during safety review, as well as known adverse events that occur more often than during clinical trials.
“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,” Gerald Dal Pan, MD, MHS, director of the Office of Surveillance and Epidemiology in the FDA’s Center for Drug Evaluation and Research, said in a press release.
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