The U.S. Food and Drug Administration (FDA) plans to rescind its laboratory developed test (LDT) rule dated May 6, 2024. The rule would have regulated LDTs as in vitro diagnostic products (IVDs) and ...
On March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in which FDA attempted to assert regulatory authority over ...
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