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

Project Title A Critical Review of Methods to Evaluate the Impact of FDA Regulatory Actions
Date
Friday, July 12, 2013
Location
Description

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
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: Becky.Briesacher@umassmed.edu

Authors

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

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