After a five-year pilot program, the U.S. Food and Drug Administration’s active surveillance system for monitoring the safety of FDA-regulated drugs and other medical products is finally transitioning to a full-scale system.

Launched in 2009, the FDA’s Mini-Sentinel pilot program has established secure access to the electronic healthcare data of more than 178 million patients across the country—principally claims data but also electronic health records—according to the regulatory agency. Building on this success, Mini-Sentinel has now morphed into the new full-scale Sentinel, envisioned by the FDA as a nationwide rapid-response electronic active surveillance system.

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