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FDA, Industry To Miss MDUFA V Congressional Deadline; Insiders At Odds Over Future Of Deal

Executive Summary

The US agency and the medtech industry still have significant disagreements, which means they will miss a 15 January deadline to send the MDUFA V user-fee deal to Congress. Insiders disagree, however, on how severe those disagreements are and when a deal can be reached.

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With Congressional Deadline Looming, FDA And Industry Schedule MDUFA Meeting

The US regulatory agency has scheduled a 3 February meeting to continue negotiating a MDUFA deal with medtech representatives. Meanwhile, top lawmakers have set a 9 February deadline to be briefed on the matter.

Top Senator ‘Disappointed’ With Missing MDUFA Package

Sen. Patty Murray said she doesn’t want more uncertainty about user fees during the COVID-19 pandemic and will move to get all the user fees renewed before they expire in September.

QUOTED. Scott Whitaker.

The US FDA and the medtech industry missed a 15 January deadline to send a user fee agreement to Congress, but AdvaMed CEO Scott Whitaker says he remains optimistic a deal will be reached soon.

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