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Jane Pine Wood JD

LDT Rule Is Now a Fact! What Will Be Consequences?

TODAY, THE NEW RULE FOR REGULATION OF LABORATORY DEVELOPED TESTS …

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Attorneys Assess Impact of FDA’s Final LDT Rule

CEO SUMMARY: Publication of the Food and Drug Administration’s final rule on laboratory developed tests (LDTs) is already causing some labs to consider withdrawing their existing LDTs because of compliance costs. Two experienced lab industry attorneys discuss aspects of the LDT rule and…

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