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PDUFA First: Fees To Support US FDA Device Center Staff

 
• By Derrick Gingery

To enhance combination product reviews, drug-fee revenue will pay for related positions in the agency's Center for Devices and Radiological Health.

Drug user-fees will support staff in US FDA's device center for the first time beginning in fiscal year 2018.

The move does not stem from altruism by pharmaceutical sponsors and FDA signing on to the PDUFA VI agreement. Rather, the money is intended to improve the review of combination...

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