The Diagnostics Pipeline: FDA Launches Pilot for Cancer Companion Diagnostic LDTs
New program aims to provide greater transparency on the recommended performance characteristics of such tests.
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LDT Reform: If Congress Won’t Do It, We Will, Says FDA
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
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
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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LDTs: Congress Set to Scuttle VALID Act at the Eleventh Hour
Congress reportedly set to pass a stripped-down version of the FDA user fees bill without the VALID Act component regulating LDTs.
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