The FDA's Sentinel Initiative—A Comprehensive Approach to Medical Product Surveillance

    Basic Details
    Date
    Tuesday, January 12, 2016
    Type
    Publication
    Description

    This article describes the FDA Sentinel Initiative, which was announced by the department of Health and Human Services in May 2008. The US Food and Drug Administration (FDA) created the Sentinel System, a national electronic system for medical product safety surveillance, to complement existing FDA surveillance capabilities.

    Author(s)

    Robert Ball MD, MPH, ScM; Melissa A. Robb RN; Stephen A. Anderson PhD, MPP; Gerald Dal Pan MD, MHS

    Corresponding Author

    R. Ball, Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 22, Silver Spring, MD, 20993. Email: Robert.Ball@fda.hhs.gov