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FDA sued over rule to regulate hospital lab tests

FDA sued over rule to regulate hospital lab tests
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FDA s Final Rule on Laboratory Developed Tests Comes with Controversy and Concerns | Holland & Knight LLP

The U.S. Food and Drug Administration's (FDA) recent announcement of a final rule extending regulatory oversight to laboratory developed tests (LDTs) has sparked controversy. As.

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An FDA Overreaction to Theranos s Implosion Would Harm Patients

Requiring FDA approval for laboratory developed tests would be an overreaction to the Theranos debacle and would ultimately harm patients

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More Medical Lab Tests Will Soon Face Federal Scrutiny, FDA Says

Laboratory tests used by millions of Americans are soon to be classified as medical devices, and as such be regulated by the U.S. Food and Drug Administration, the agency announced Monday. Laboratory tests used by millions of Americans are soon to be classified as medical devices, and as such be regulated by the U.S. Food and Drug Administration, the agency announced Monday.

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FDA brings lab tests under federal oversight in bid to

The Food and Drug Administration has finalized a rule to regulate medical tests that have long escaped oversight

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