Sentinel’s tall order
This article was originally published in The Gray Sheet
Executive Summary
FDA plans to request quotations June 1 from vendors interested in creating an active medical product surveillance system for the agency's Sentinel post-market safety initiative, FDA says in a May 15 FedBizOpps.gov notice. The selected vendor would develop a system to detect and analyze adverse event data from automated health care data systems, including electronic health records, claims databases and registries. Data should contain drug and biologic utilization, and ideally medical device utilization information, as well