FDA will provide safety updates for approved products

July 1, 2010

FDA will now periodically prepare and post summaries of safety analyses on recently approved products as well as steps the agency is taking to address safety issues.

FDA has announced that the agency will now periodically prepare and post summaries of safety analyses on recently approved products as well as steps that the agency is taking to address safety issues.

The summaries will include safety data from reports provided by manufacturers, healthcare providers, and consumers to the FDA's Adverse Event Reporting System and the Vaccine Adverse Event Reporting System, maintained by the FDA and by the Centers for Disease Control and Prevention (CDC). The summaries will also include periodic safety information provided by manufacturers, information from medical literature, and data from ongoing trials.

The summaries will include information on serious previously unidentified risks and adverse events that occur more frequently than they did during clinical trials.