The U.S. Food and Drug Administration's Mini-Sentinel Program: Status and Direction

Project Title The U.S. Food and Drug Administration's Mini-Sentinel Program: Status and Direction
Date
Thursday, January 19, 2012
Location
Description

This paper provides an overview of the development, current status, and direction of the FDA’s Mini-Sentinel pilot, including methods, tools, resources, policies, and procedures to facilitate the use of routinely collected electronic healthcare data to perform active surveillance of the safety of marketed medical products, including drugs, biologics, and medical devices.

Corresponding Author

R. Platt, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA. E-mail: Richard_Platt@harvard.edu

Authors

Richard Platt MD, MSc; Ryan M. Carnahan PharmD, MS, BCPP; Jeffrey S. Brown PhD; Elizabeth Chrischilles PhD, MS; Lesley H. Curtis PhD; Sean Hennessy PharmD, PhD; Jennifer C. Nelson PhD; Judith A. Racoosin MD, MPH; Melissa Robb RN; Sebastian Schneeweiss MD, ScD; Sengwee Toh ScD; Mark G. Weiner MD