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FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | Goodwin

On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug.

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What You Should Know About The FDA's New Final Rule On LDTs

What You Should Know About The FDA's New Final Rule On LDTs
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United States - Healthcare - FDA Issues Final Rule To Regulate Laboratory-Developed Tests As Medical Devices

United States - Healthcare - FDA Issues Final Rule To Regulate Laboratory-Developed Tests As Medical Devices
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FDA Final Rule Regulates LDTs as Medical Devices

FDA Final Rule Regulates LDTs as Medical Devices
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FDA's Final Rule and LDT Regulation Shift

FDA's Final Rule and LDT Regulation Shift
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