Author Affiliations: Cardiovascular Health Research Unit, Departments of Medicine (Drs Psaty and Larson), Epidemiology (Dr Psaty), and Health Services (Dr Psaty), University of Washington, Seattle; and Group Health Research Institute, Group Health Cooperative, Seattle (Drs Psaty and Larson).
Active surveillance of drugs and devices in the postmarket setting is an essential component of the lifecycle approach to drug evaluation. The US Food and Drug Administration (FDA) Amendments Act of 2007 (PL 110-85) required the agency to develop “a postmarket risk identification and analysis system.” In response, scientists from the FDA and investigators from collaborating institutions have been actively and productively engaged in the creation of the Sentinel Initiative, including the Mini-Sentinel pilot program,1 which has become an exciting and powerful research resource.
Psaty BM, Larson EB. Investments in Infrastructure for Diverse Research Resources and the Health of the Public. JAMA. 2013;309(18):1895–1896. doi:10.1001/jama.2013.3445