FDA's Sentinel Initiative
- Registration Open! The 4th Annual Sentinel Initiative Public Workshop
- FDA Mini-Sentinel Pilot Demonstrating Rapid Analysis of Medical Product Safety Questions (PDF - 59KB)
- Mini-Sentinel Website Launched
Report to Congress 8/19/11(PDF - 240KB)
Monitoring the safety of its regulated products is a major part of FDA’s mission to protect public health. The Sentinel System would enable FDA to actively query diverse automated healthcare data holders—like electronic health record systems, administrative and insurance claims databases, and registries—to evaluate possible medical product safety issues quickly and securely.
Sentinel will be developed and implemented in stages. As the system is envisioned, data would continue to be managed by its owners and questions would be sent to the participating data holders. Within pre-established privacy and security safeguards, these data holders would evaluate their information and send summary results to FDA. It is also anticipated that Sentinel will facilitate the development of active surveillance methodologies related to signal detection, strengthening, and validation.
- FDA's "Mini-Sentinel" safety pilot program is up and running, demonstrating rapid analysis of medical product safety questions (PDF - 59KB)3
- Mini-Sentinel Pilot45
Critical Path Initiative6