News & Analysis as of

Final Rules Regulatory Authority

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

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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

Cooley LLP

President Trump Directs Federal Agencies on How to Repeal ‘Unconstitutional’ Rules

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On April 11, 2025, a new rule went into effect in which the United States government will start to strictly enforce the requirement that foreign nationals register their presence with U.S. Citizenship and Immigration Services...more

Ballard Spahr LLP

Republicans ask federal banking agencies to withdraw rules, guidance

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Republicans on the House Financial Services Committee have sent letters to financial regulators asking them to rescind a variety of measures the regulators issued during the Biden Administration....more

Bricker Graydon LLP

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

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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

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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

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

Foley & Lardner LLP

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

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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

Vedder Price

SEC Revokes Enforcement Division's Formal Investigation Authority

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On March 10, 2025, the SEC voted along party lines to amend SEC regulations in order to rescind the SEC’s delegation of authority to the Director of the Division of Enforcement to issue formal orders of investigation. The SEC...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

Nelson Mullins Riley & Scarborough LLP

New Rule on SEC Delegation of Authority to Director

On March 10, 2025, the U.S. Securities and Exchange Commission (SEC) announced its final rule rescinding the delegation of authority that had allowed the SEC’s Director of the Division of Enforcement’s (“Director”) to “issue...more

Morrison & Foerster LLP

Take it to the Top: The SEC Rescinds Its Delegation to the Enforcement Division to Issue Formal Orders

To issue a subpoena for documents or testimony, Enforcement staff must first obtain a formal order. A formal order authorizes SEC staff “to administer oaths and affirmations, subpoena witnesses, compel their attendance, take...more

Bennett Jones LLP

PMRA Publishes Final Guidance and Section 66 Agreement for Data Compensation for Re-evaluation and Special Reviews Published Prior...

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Following stakeholder consultations in the fall of 2024, on March 6, 2025, Health Canada's Pest Management Regulatory Authority (PMRA) released the final guidance document and the Section 66 Agreement under the Pest Control...more

Troutman Pepper Locke

Credit Card Late Fee Rule Litigation: CFPB Indicates “Resolution is Feasible”

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In a significant development in the credit card late fee rule litigation, the Consumer Financial Protection Bureau (CFPB) has filed a status report indicating that it is actively working towards a resolution. This update...more

Proskauer - Health Care Law Brief

HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking

On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more

Ballard Spahr LLP

SEC Curtails Enforcement Leadership’s Investigation and Subpoena Power, Signals Greater Commissioner Oversight Over Enforcement

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On Monday, March 10, 2025, the SEC announced a new final rule revoking the Director of Enforcement’s previous authority to issue formal orders, which have the effect of officially initiating investigations and permitting...more

Pillsbury Winthrop Shaw Pittman LLP

Council on Environmental Quality Rescinds NEPA Regulations

Federal agencies are now responsible for their own National Environmental Policy Act procedures, creating uncertainty and opportunity for federal environmental reviews....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

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

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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

Latham & Watkins LLP

FDA Finalizes Guidance on Communications of Scientific Information on Unapproved Uses

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The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more

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