News & Analysis as of

Final Rules Appeals Regulatory Authority

DLA Piper

FTC “Click-to-Cancel” Rule to Take Effect May 14

DLA Piper on

In October 2024, the Federal Trade Commission (FTC) finalized significant updates to the Negative Option Rule, which are slated to take effect on May 14, 2025. A negative option is a contract term under which a buyer agrees...more

Morgan Lewis - Health Law Scan

Courts Diverge in Challenges to CMS's Minimum Staffing Requirements for LTC Facilities

On May 10, 2024, the Centers for Medicare and Medicaid Services (CMS) published its Final Rule to implement minimum staffing standards for long-term care (LTC) facilities in the United States. However, as discussed in our...more

Jones Day

Judge Blocks FDA Regulation of Laboratory-Developed Tests

Jones Day on

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

Husch Blackwell LLP

Federal Court Vacates FDA's Final Rule on Laboratory-Developed Tests

Husch Blackwell LLP on

On March 31, 2025, the Eastern District of Texas issued a decision in the case brought by the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP), challenging the FDA’s final rule...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

Venable LLP

Federal District Court Vacates FDA’s LDT Final Rule

Venable LLP on

On March 31, 2025, the U.S. District Court for the Southern District of Texas vacated the FDA’s Final Rule on laboratory-developed tests (LDTs), holding that the agency lacks authority to regulate LDTs as medical devices...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

McDermott Will & Emery

Federal Court Strikes Down LDT Final Rule

On March 31, 2025, the US District Court for the Eastern District of Texas struck down the US Food and Drug Administration’s (FDA) final rule under which FDA would have started regulating most laboratory-developed tests...more

Faegre Drinker Biddle & Reath LLP

Supreme Court Decides Bondi, Attorney General, et al. v. Vanderstok, et al.

On March 26, 2025, the Supreme Court decided Bondi, Attorney General, et al. v. Vanderstok, et al., No. 23-852, and held that the Bureau of Alcohol, Tobacco, Firearms, and Explosives’ (ATF) rule interpreting the Gun Control...more

Parker Poe Adams & Bernstein LLP

Fifth Circuit Declines Reconsideration of FLSA Salary Rule Decision

Last year in a rare victory for the Department of Labor, the Fifth Circuit Court of Appeals rejected a claim by a Dairy Queen franchisee that the Fair Labor Standards Act prohibits DOL from establishing any minimum salary for...more

BakerHostetler

Federal Court Blocks FDA’s Graphic Cigarette Warning Rule: The Limits of Regulatory Authority

BakerHostetler on

On Monday, a federal judge from the Eastern District of Texas, Judge J. Campbell Barker, ruled that the U.S. Food and Drug Administration (FDA) exceeded its authority under the Tobacco Control Act by requiring cigarette...more

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