The Ensuring Patient Access to Critical Breakthrough Products Act of 2024 (HR1691) was approved by the US House Committee on Ways & Means on 27 June, supported by an amendment that tightened the criteria for breakthrough devices to be covered by the pathway.
Amendments To Breakthrough Device Coverage Act Push Bill Out Of House Ways And Means Committee
The amendment introduced to the Ensuring Patient Access to Critical Breakthrough Products Act in the Ways and Means committee markup of helped usher the legislation to a passing vote.

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Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
About 200 staff in the FDA’s Center for Devices and Radiological Health were among the 3,500 FDA employees let go in today’s staff reductions. The cuts, which one employee described as a “Manhattan Project” to the center, are already having a major effect on staff morale.
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