10 May 2016 - With access to claims data on about 200 million patients and 5.5 billion patient encounters across the United States, the US FDA’s Sentinel Initiative has grown into a juggernaut of patient experience since its pilot program launched in 2008.

In the past year, the system has transitioned out of the “mini” phase, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), said during the annual Sentinel Initiative Public Workshop hosted in February by the Duke-Margolis Center for Health Policy.

“Sentinel has become an important part of our routine safety surveillance,” Woodcock said at the workshop.

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