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.
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