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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

Loper Bright & Corner Post Review: Supreme Court’s Overturning of Chevron Doctrine Spells Uncertainty for Food Industry...

Loper Bright Review: The Death of Chevron Deference? On June 28, 2024, the U.S. Supreme Court overturned the Chevron doctrine of agency deference in its Loper Bright Enterprises v. Raimondo decision. The doctrine takes...more

Supreme Court Decides Corner Post, Inc. v. Board of Governors of the Federal Reserve System

On July 1, 2024, the Supreme Court decided Corner Post, Inc. v. Board of Governors of the Federal Reserve System, No. 22-1008, holding that a facial claim against enforcement of a regulation accrues under the Administrative...more

Supreme Court Decides Loper Bright Enterprises v. Raimondo

On June 28, 2024, the Supreme Court issued its decision in Loper Bright Enterprises v. Raimondo, No. 22-451, overruling the doctrine of Chevron deference and holding that courts “must exercise their independent judgment in...more

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