The Food and Drug Administration has launched a Web page where it will post newly identified adverse-event information for recently approved drugs and biologics.
The Web page will be accessible to the public and will feature safety information that emerges during a product's post-approval life cycle. Summary postings will be culled from items submitted to the FDA's Adverse Event Reporting System and the Vaccine Adverse Event Reporting System as well as other sources.
“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, director of the Office of Surveillance and Epidemiology in the FDA's Center for Drug Evaluation and Research.
The summary reports will include information about previously unidentified risks and adverse events that occur more frequently than they did during clinical-trial studies. Reports also will describe the actions the FDA is taking to address the safety concerns.