1. Pink Sheet

US FDA's Sentinel To Begin Expansion This Fall

 
• By Derrick Gingery

Contracts for up to $220m to develop three new Sentinel centers will be awarded in September.

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The FDA's Sentinel program has grown from a small pilot to a fully mature program. • Source: Shutterstock

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...

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