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Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act

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 laboratory-developed...more

Republican State AGs Challenge CMS Rule Redefining 'Lawfully Present' for ACA Eligibility Under Administrative Procedure Act (APA)

On August 8, 2024, thirteen Republican state attorneys general brought suit in the District of North Dakota against the Centers for Medicare & Medicaid Services (CMS) to challenge the agency’s recent rule allowing...more

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