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.
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FDA Begins ‘Soft’ TAP, Will Phase In Pilot Over Five Years
The US Food and Drug Administration has rolled out a program designed to speed up the development of innovative medical devices. The Total Product Lifecycle Advisory Program pilot was authorized under MDUFA V.
Pilot Program Aimed At Advancing Medical Device Development Set To Launch
The US Food and Drug Administration’s Total Product Lifecycle Advisory Program pilot, which was authorized under MDUFA V, will begin rolling out next year. The program is designed to speed up the development of innovative medical devices and make them more readily available to patients.
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.