Janice Hogan

Janice Hogan

Hogan Lovells

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Federal court vacates FDA Laboratory Developed Test rule

Yesterday, the U.S. District Court for the Eastern District of Texas vacated the U.S. Food and Drug Administration’s 2024 rule that aimed to regulate laboratory-developed tests (LDTs) as medical devices, deciding it is...more

4/2/2025  /  Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Regulatory Authority , Regulatory Requirements
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