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Pop The Champagne: Medtech Industry, FDA Reach MDUFA V User-Fee Deal

 
• By Elizabeth Orr

The deal includes a $110m Total Product Lifecycle Advisory Program pushed for by the US agency, but also credits unused funds past a certain threshold back to industry.

popping champagne on black background
• Source: Alamy

The US Food and Drug Administration and medtech industry groups have come to an agreement in the protracted Medical Device User Fee Amendment (MDUFA V) talks, the agency confirmed on 9 March.

This is not quite two months later than the official 15 January deadline to get user-fee agreements to Congress. At...

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