Investments in Infrastructure for Diverse Research Resources and the Health of the Public

Project Title Investments in Infrastructure for Diverse Research Resources and the Health of the Public
Date
Wednesday, May 8, 2013
Location
Description

This article discusses 1) active surveillance of drugs and devices in the postmarket setting as an essential component of the lifecycle approach to drug evaluation and 2) creation of the FDA’s Sentinel Initiative, including the Mini-Sentinel pilot program, for postmarket risk identification and analysis.

Corresponding Author

B. M. Psaty, Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, and Health Services, University of Washington, Seattle, WA. Email: psaty@u.washington.edu

Authors

Bruce M. Psaty MD, PhD; Eric B. Larson MD, MPH