US FDA's Sentinel To Begin Expansion This Fall

The US Food and Drug Administration is reviewing proposals for a dramatic expansion of its Sentinel Initiative that would support new analysis methods, more data access and more drug safety and efficacy studies.

Sentinel, the FDA's electronic system that uses insurance claim, electronic health record (EHR) and other data to monitor the safety of drugs, biologics, vaccines and medical devices, would grow into three new centers, according to proposal documents: an Operations Center,