Diagnostics Reform Out As Congress Reaches Year-End Omnibus Compromise
A measure that would have moved diagnostics regulation under the US Food and Drug Administration has been culled from the year-end omnibus spending package.
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Hillebrenner Fields Questions On FDA’s Proposed Rule To Regulate LDTs, Says No To Extended Comment Period
During a recent webinar, Elizabeth Hillebrenner of the US FDA’s device center sought to clarify specifics on the agency’s proposed rule to regulate laboratory-developed tests, which establishes FDA oversight of the tests over a five-year period.
The VALID Act, which will hand diagnostics oversight to the US FDA, has been reintroduced in the House of Representatives after it failed twice last year in Congress.
The FDA requested a 10% increase in budget authority for FY 2024, but diagnostic reform was left out of the proposal.