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The U.S. Food and Drug Administration's Sentinel Initiative: Expanding the Horizons of Medical Product Safety

    Basic Details

    This article describes 1) the impetus behind FDA’s efforts to identify and investigate postmarket safety signals related to regulated medical products, 2) Agency goals and activities in this area, and 3) the role of the Mini-Sentinel pilot in the development of their larger Sentinel Initiative.


    Melissa A. Robb RN; Judith A. Racoosin MD, MPH; Rachel E. Sherman MD, MPH, FACP; Thomas P. Gross MD; Robert Ball MD, MPH, ScM; Marsha E. Reichman PhD; Karen Midthun MD; Janet Woodcock MD, MPH

    Corresponding Author

    M. A. Robb, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Building 51, Room 6360, Silver Spring, MD 20993, USA. E-mail: