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Loper Bright Renews Interest in the VALID Act

Loper Bright Renews Interest in the VALID Act

by Christine P. Bump | Aug 30, 2024 | Essential, Lab Industry Advisor, Legislation-lca

The US Supreme Court decision that recently overturned the Chevron doctrine is influencing potential enactment of new legislation

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Will LDTs Soon Be Regulated?

Will LDTs Soon Be Regulated?

by Rachel Muenz | Sep 6, 2023 | News, Open Content

The FDA recently submitted its own proposed rule relating to lab-developed test regulation for review.

LDT Reform: If Congress Won’t Do It, We Will, Says FDA

LDT Reform: If Congress Won’t Do It, We Will, Says FDA

by Glenn S. Demby | Mar 13, 2023 | Essential, Legislation-nir, National Lab Reporter

Hopes are high that something will finally be done to resolve the LDTs situation this year, however that action may not come from Congress.

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Five Key Changes Affecting Labs in the New Spending Bill

by Glenn S. Demby | Jan 19, 2023 | Essential, Legislation-nir, National Lab Reporter

While the federal spending bill passed at the end of 2022 will have a large impact on clinical labs, it doesn’t include LDTs reform.

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Despite MDUFA Setback, VALID Act Is Back on Track for Passage

Despite MDUFA Setback, VALID Act Is Back on Track for Passage

by Glenn S. Demby | Oct 14, 2022 | Essential, Legislation-nir, National Lab Reporter

Though Congress didn’t pass VALID as part of the medical devices user fees bill, there’s still a good chance it will pass before year’s end.

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