Pop The Champagne: Medtech Industry, FDA Reach MDUFA V User-Fee Deal
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.
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FDA Releases Draft Device User Fee Agreement
The agreement could land the FDA almost $20bn in user fees between 2023 and 2027.
MDUFA Negotiations Go Into Overdrive
The US FDA and industry have scheduled five meetings over the next two weeks to negotiate a device user fee deal. Both sides are under pressure from lawmakers to come to an agreement.
MDUFA V: Industry, FDA Tangle Over TAP Program, Agency Finances, Reinstatement Of Fifth-Year Offset Funds
In newly published meeting minutes, industry and the US FDA continued to clash over a proposal to create a new pre-submission advisory program and what to do with carryover user-fee funds.