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User-Fee Renewal Passes US House, 392-28

Senate hearing set for next week

Executive Summary

The legislative package, which sets user-fee amounts through 2027, funds a bevvy of FDA activities and improvements.

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Senate Bill Establishes Greater Regulatory Oversight Of Lab Developed Tests

Draft legislation out of the US Senate Health, Education, Labor and Pensions (HELP) Committee gives the FDA authority to regulate certain in vitro diagnostics known as laboratory developed tests.

MDUFA V Passed By US House Health Subcommittee

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

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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