Legislators Question FDA, Stakeholders on How LDT Oversight Impacts Industry, Patients, Innovation | GenomeWeb

Originally published Sept. 9.

NEW YORK (GenomeWeb) – Members of the US Congress today grilled a US Food and Drug Administration official regarding the agency's legal authority to regulate lab-developed tests (LDTs), asking whether new requirements would trigger additional costs and taxes upon laboratories, and whether the FDA itself had the necessary resources to take on this enormous task.

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