Methods to Evaluate Impact of FDA Regulatory Actions

Project Title Methods to Evaluate Impact of FDA Regulatory Actions
Date Posted
Thursday, January 24, 2013
Status
Complete
Deliverables
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 Members

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

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