Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Episode 18 | Unpacking the Packing: A Perspective on the Efforts to Expand the Supreme Court
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
On April 7, 2025, the United States District Court for the Northern District of Texas vacated staffing requirements published in the Centers for Medicare & Medicaid Services (CMS) May 2024 Minimum Staffing Rule (the “Final...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 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
The order is in, and the LDT Final Rule is out. In May 2024, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published its Final Rule establishing its regulatory framework over laboratory developed tests...more
In this edition of Insights, we take a closer look at the megadeals and sponsor transactions driving recent M&A activity, the importance of staying ahead of the risks in AI development and deployment, and other diverse...more
This month, the Supreme Court put an end to “Chevron deference,” the decades-long practice of judicial deference to federal agency interpretations of ambiguous statutory language. What does this mean for employers? Well,...more
On June 28, the Supreme Court handed down Loper Bright Enterprises v. Raimondo, which overturned the prior Supreme Court precedent, articulated in Chevron v. Natural Resource Defense Council, Inc. and known as “the Chevron...more