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Expert Analysis

FDA Takes Another Step Toward Regulating LDTs

Law360, New York (October 9, 2014, 10:40 AM EDT) -- On Oct. 1, 2014, the U.S. Food and Drug Administration took the next step toward regulating laboratory developed tests by publishing its new plan to regulate LDTs in the form of two draft guidance documents: "Framework for Regulatory Oversight of Laboratory Developed Tests" (the Framework Guidance) and "FDA Notification and Medical Device Reporting for Laboratory Developed Tests" (the Notification Guidance).[1]...

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