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US FDA’s Shuren Promises MDUFA Update ‘Relatively Soon’

FDA device center director Jeff Shuren told Medtech Insight he anticipates MDUFA V negotiation minutes that have not been published in four months will be available imminently.

FDA building.

The US Food and Drug Administration has been silent on how the Medical Device User Fee Amendments (MDUFA V) negotiations are going for the past four months, but the head of its device center says he anticipates details will be available soon.

Center for Devices and Radiological Health director Jeff Shuren spoke about the FDA’s work on 27 September at AdvaMed’s The MedTech Conference

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