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Congressional Subcommittee Hears Testimony on FDA LDT Rule

Lab industry stakeholders warn members of Congress about the flaws in the FDA’s plan to regulate LDTs

DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommittee on Health, key members of Congress came under fire from representatives of clinical laboratory groups over the Food and Drug Administration’s (FDA’s) proposed rule to regulate laboratory developed tests (LDTs). The participants also disagreed over whether the Verifying Accurate, Leading-edge IVCT …

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