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MDUFA V Passed By US House Health Subcommittee

Executive Summary

The user fee package was among several health-related bills that the subcommittee took up on Wednesday.

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QUOTED. Cathy McMorris-Rodgers.

US House of Representatives Energy and Commerce committee ranking member Rep. Cathy McMorris-Rodgers, R-WA, raised questions about the $3bn earmarked for new health research agency ARPA-H during user fee hearings on 11 May.

FDA Holds Only Public Meeting On MDUFA V Package

Stakeholders expressed support for the proposal at the Tuesday meeting – along with some reservations.

FDA’s Shuren Grilled About Handling Of MDUFA V At House Hearing

Jeff Shuren, the director of the US agency’s device center, was quizzed by the House health subcommittee on why the new user-fee deal had reached Congress late and why there was an apparent lack of transparency around the negotiation process, among other issues. Shuren said part of the delay was due to the center and industry being “hammered by COVID.” 

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