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 could have long-term ramifications for labs that use LDTs. Action to increase regulatory oversight of laboratory-developed tests (LDTs) …

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FDA Expected to Publish Proposed LDT Rule in August

At the same time, the VALID Act is again before Congress to give FDA oversight of laboratory-developed tests

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