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Husch Blackwell LLP

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

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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

ArentFox Schiff

FDA’s Attempt to Regulate Lab-Developed Tests Struck Down in Federal Court

ArentFox Schiff on

On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and...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

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

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

Husch Blackwell LLP

What Constitutes Parity? The ERISA Industry Committee’s Lawsuit Challenging the 2024 Final Rule

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On January 17, 2025, the ERISA Industry Committee (ERIC) filed a lawsuit in the U.S. District Court for the District of Columbia, claiming that the 2024 Mental Health Parity and Addiction Equity Act (MHPAEA) Final Rule...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

Bass, Berry & Sims PLC

Chevron No More: The Impact on Benefit Plans

Bass, Berry & Sims PLC on

On June 28, 2024, the Supreme Court issued its opinion in Loper Bright Enterprises v. Raimondo, Secretary of Commerce and Relentless, Inc. v. Department of Commerce (Loper Bright), overturning Chevron U.S.A. Inc v. Natural...more

Bass, Berry & Sims PLC

Healthcare Private Equity: What to Expect for the Rest of 2024

Bass, Berry & Sims PLC on

Although the U.S. healthcare industry has weathered the storm over the past couple of years, we may be reaching calmer waters in the coming months. Dry powder held by U.S. private equity investors has reached an all-time...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

WilmerHale

Antitrust Updates: The FTC's Non-Compete Rule and the Impact of Loper Bright on Federal Antitrust Enforcement

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On June 28, the Supreme Court handed down its decision in Loper Bright Enterprises v. Raimondo, overruling Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc. In its 1984 Chevron decision, the Court held that...more

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