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

Basic Details
Date Posted
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.

Deliverable(s) (1)
Mini-Sentinel Methods Impact of FDA Regulatory Actions White Paper
Related Links
Related Link(s)
A Critical Review of Methods to Evaluate the Impact of FDA Regulatory Actions
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