Posted by Michael Wonder on 02 Oct 2017
Statement from FDA Commissioner Scott Gottlieb on the FDA’s adverse event reporting system and new search tool
2 October 2017 - The FDA’s adverse event reporting system is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that are submitted to the FDA.
The database is used as a surveillance tool to help the agency look for new safety concerns that might be related to a marketed product.
It is also used to evaluate a manufacturer's compliance with reporting regulations and responding to outside requests for information.
