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On Eve Of House Hearing, FDA Makes Its Case For LDT Framework

The agency details 20 case studies to support its planned framework for regulating laboratory-developed tests in a report issued the day before a House subcommittee held a hearing on alternative legislative schemes.

FDA advocated for its proposed laboratory developed test framework in advance of a House subcommittee hearing that focused on proposals to replace FDA’s plan with a completely new regulatory scheme for diagnostics. The agency issued a report

Nov. 16 detailing how lack of LDT oversight may be causing significant harm to patients.

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