Investments in Infrastructure for Diverse Research Resources and the Health of the Public

    Basic Details
    Date
    Wednesday, May 8, 2013
    Type
    Publication
    Description

    This article discusses 1) active surveillance of drugs and devices in the postmarket setting as an essential component of the lifecycle approach to drug evaluation and 2) creation of the FDA’s Sentinel Initiative, including the Mini-Sentinel pilot program, for postmarket risk identification and analysis.

    Author(s)

    Bruce M. Psaty MD, PhD; Eric B. Larson MD, MPH

    Corresponding Author

    B. M. Psaty, Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, and Health Services, University of Washington, Seattle, WA. Email: psaty@u.washington.edu