Brookings Roundtable on Active Medical Product Surveillance: Overview of FDA’s Sentinel Initiative

It has been three years since FDA launched the Sentinel Initiative and, since then, FDA has made significant progress. On September 7, the Engelberg Center hosted the first of the three-part Sentinel Initiative 101 Webinar Series, “Overview of FDA’s Sentinel Initiative” to review ongoing activities and accomplishments. The roundtable featured a presentation from Dr. Judy Racoosin, Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration.

Dr. Racoosin’s presentation provided a high-level review of the Sentinel Initiative’s scope and achievements including:

• FDA’s 3-year vision for the Sentinel Initiative
• A brief overview of the role of the Mini-Sentinel pilot, the Observational Medical Outcomes Partnership, the Federal Partners Collaboration, and the Brookings Institution cooperative agreement
• Next steps for the Sentinel Initiative

Subsequent webinars in this series will provide a more in-depth overview of these pilot activities.