Mini-Sentinel: Methods to Evaluate Impact of FDA Regulatory Actions

    Basic Details
    Date Posted
    Thursday, January 24, 2013
    Status
    Complete
    Description

    Methods project to examine current design and analytic approaches used to evaluate the impact of FDA regulatory actions, to identify gaps and key characteristics that may impact design and analytic choices, and to make recommendations concerning useful and valid methods.

    The final report for this project was updated in November 2012.

    Workgroup Leader(s)

    Becky A. Briesacher, PhD; Division of Geriatric Medicine, University of Massachusetts Medical School and Meyers Primary Care Institute, Worcester, MA

    Azadeh Shoaibi, MS, MHS; Office of Medical Policy, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

    Workgroup Member(s)

    Stephen B. Soumerai, ScD; Darren Toh, ScD; Fang Zhang, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Susan Andrade, ScD; Jerry H. Gurwitz, MD; Division of Geriatric Medicine, University of Massachusetts Medical School and Meyers Primary Care Institute, Worcester, MA

    Joann L. Wagner, MSW; Meyers Primary Care Institute, Worcester, MA 

    Antonio Paredes, PhD; Center for Biologics and Evaluation and Research, FDA, Silver Spring, MD

    Marsha E. Reichman, PhD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD