FDA Sentinel Initiative Strategic Review

Three years ago, the U.S. Food and Drug Administration (FDA) launched the Sentinel Initiative, making significant progress in developing a system for conducting active surveillance of medical products.  On September 26-27, the Engelberg Center hosted an event to reflect on the progress of the Initiative to date, and to consider its future direction and sustainability.

This event brought together a diverse set of stakeholders to reflect on the progress of the Initiative made to date, and consider its future direction to ensure sustainability of the system and reliability of results generated, including:

• Potential pathways that others outside of FDA (e.g., industry, academic safety scientists, etc) can access the resources and tools developed through the Mini-Sentinel pilot;
   
• Alignment of national priorities for safety science methods research and development, and training opportunities for the next generation of safety scientists; and
   
• Development of a national resource for evidence development by identifying synergies with related initiatives