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Jones Day

Judge Blocks FDA Regulation of Laboratory-Developed Tests

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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

Bricker Graydon LLP

CMS Final Rule on Minimum Staffing Standards for Long-Term Care Facilities Struck Down

Bricker Graydon LLP on

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

Mintz - Health Care Viewpoints

A Texas Federal Court Sides with Laboratories, But There May Be Unintended Consequences for FDA

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

Foley & Lardner LLP

Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final Rule

Foley & Lardner LLP on

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

Epstein Becker & Green

A Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs

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

Skadden, Arps, Slate, Meagher & Flom LLP

Insights - September 2024

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

Bradley Arant Boult Cummings LLP

What Does the End of Chevron Deference Really Mean for Employers?

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

Schwabe, Williamson & Wyatt PC

Supreme Court Opinions Overturn Chevron and Modify the Statute of Limitations Allowed by Lower Courts

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

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