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

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    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

    Mark McClellan MD, PhD, MPA; Engelberg Center for Health Care Reform, Brookings Institution, Washington, DC


    Judy Racoosin MD, MPH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Springs, MD