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On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more
In our May 2024 Healthcare Alert, we discussed a final rule published by the US Food and Drug Administration (FDA) amending its regulations to include in vitro diagnostic products (IVDs), even those manufactured in a...more
The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology,...more
A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more
A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical...more