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A Critical Review of Methods to Evaluate the Impact of FDA Regulatory Actions

    Basic Details

    The article describes a Mini-Sentinel project to conduct a synthesis of the literature on methods to evaluate the impact of FDA regulatory actions and to identify best practices for future evaluations.  Specific objectives included: 1) characterizing prior research approaches used to evaluate FDA regulatory actions, particularly in regard to the strengths and weaknesses of previous methodologies, and 2) recommending designs and statistical approaches that may be useful for evaluating FDA regulatory actions and describing the advantages and disadvantages of each approach.

    Time Period
    1948 - 2011

    Becky A. Briesacher PhD; Stephen B. Soumerai ScD; Fang Zhang PhD; Sengwee Toh ScD; Susan Andrade ScD; Joann L. Wagner MSW; Azadeh Shaoibi PhD, MS, MHS; Jerry H. Gurwitz MD

    Corresponding Author

    B. A. Briesacher, Division of Geriatric Medicine, University of Massachusetts Medical School, Biotech Four, Suite 315, 377 Plantation Street, Worcester, MA 01605, USA. E-mail: