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Food Drug and Cosmetic Act

Congressional Subcommittee Hears Testimony on FDA LDT Rule

DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommitt…

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CMS Issues AI Guidance for Medicare Advantage

CEO SUMMARY: With its guidance on how Medicare Advantage plans should use artificial intelligence (AI) when making treatment decisions involving individual patients, the federal Centers for Medicare and Medicaid Services has opened one door in the coming debate on how the federal governme…

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FDA Expected to Publish Proposed LDT Rule in August

CEO SUMMARY: Congressional lawmakers and the federal Food and Drug Administration are again eyeing changes that would bring greater oversight to laboratory-developed tests (LDTs). Leaders at clinical laboratories and pathology groups should monitor these proposals, both of which c…

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