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Diagnostics Reform Out As Congress Reaches Year-End Omnibus Compromise

 
• By Elizabeth Orr

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.

Capitol House

The year-end omnibus spending bill, expected to pass through the US Congress this week, will not include proposed diagnostics reform, a review of the bill’s text shows.

This marks a second and quite possibly final death for the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would have moved regulation of lab-developed tests (LDTs) from the Center for Medicare and Medicaid Services (CMS) to the US Food and Drug Administration. The first came last summer when the bill was removed from the FDA user fee reauthorization package in a bit of last-minute political wrangling

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