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Read the Tea Leaves… FDA Will Require LDT Review

PROPOSED FEDERAL REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) IS CURRENTLY THE HOT-BUTTON ISSUE within the clinical laboratory industry. Following the close of public comments on Dec. 4, it is the quiet period while the federal Food and Drug Administration (FDA) reviews the comments and considers changes to the draft rule it issued on Sept. 29, …

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