US Interim Funding Bill Gets President Biden’s Signature; Window Narrows For IVD Reg Reform
Passed by the US House and signed into law on 30 September, the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, avoids a partial government shutdown and furloughs in FDA user-fee programs including MDUFA. Policy riders stripped from the legislation, including for FDA oversight of lab-developed tests, could still find their way into a final FY 2023 spending omnibus.
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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.
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Committee leaders in the US Congress have agreed on a stripped-down path to user fee reauthorization, which will not include FDA oversight of diagnostic tests.