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$30m In Device User Fees Will Go To Real-World Evidence Evaluation System

 
• By Sue Darcey

US FDA will be able to tap $30m in user fees over a five-year span to support an independent coordinating center for collection of real-world evidence under its nascent NEST program, according to device center Director Jeff Shuren.

FDA will get $30m in device industry user fees over five years to help fund broader use of real-world evidence for devices in the US.

The agency and industry negotiators announced a draft MDUFA IV agreement last month, which will form the basis of the user-free program that stretches from fiscal years 2018 through 2022....

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