News & Analysis as of

Administrative Procedure Act Statutory Interpretation

Shumaker, Loop & Kendrick, LLP

Client Alert: The Trump Administration Issues Guidance to Repeal Regulations

On April 9, 2025, the Trump Administration issued guidance that calls for the massive repeal of regulations throughout federal agencies. The guidance cites multiple Supreme Court decisions, including Loper Bright Enterprises...more

Goulston & Storrs PC

AG's Power Holds, but Agency Shortcuts Don't

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In Att’y Gen. v. Town Milton, the court ruled that the Massachusetts Bay Transportation Authority (“MBTA”) Communities Act, G. L. c. 40A, § 3A (“Section 3A”), is constitutional, and that the Attorney General has the authority...more

Bradley Arant Boult Cummings LLP

Bid Protests in Utah

Bradley has been publishing an ongoing survey of state-level bid protest processes and procedures. For the next state in this series, we focus on the protest process in Utah. What Rules Apply? Protests of state-level...more

Kilpatrick

4 Key Takeaways | The Top 10 Sales and Tax and Income Tax Cases

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Kilpatrick’s David Hughes recently participated in a panel titled - “The Top 10 Sales Tax and Income Tax Cases” - at the Council on State Taxation (COST) Annual Spring Meeting in New Orleans. David and his fellow thought...more

Vedder Price

President Trump Issues Executive Action Directing the Repeal of Unlawful Regulations

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On April 9, 2025, President Trump issued a presidential memorandum (the order) directing the heads of all Federal agencies to identify unlawful or potentially unlawful regulations that clearly exceed the agency’s statutory...more

Best Best & Krieger LLP

Federal Wildlife Agencies Propose Rescinding Definition of “Harm” Under Endangered Species Act

On April 17, 2025, the U.S. Fish and Wildlife Service and National Marine Fisheries Service (Services) proposed a rule to rescind the regulatory definition of “harm” under the Endangered Species Act (ESA). The proposed rule...more

Snell & Wilmer

Agencies to Use Good Cause Exception to Repeal Illegal Regulations

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Recently, President Donald Trump directed agencies to take steps to immediately repeal illegal regulations under the good cause exception to the notice-and-comment requirement. Because this latest effort could have...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Estoppel Certification in Reexamination

Estoppel certification in reexamination prevents relitigation of resolved issues....more

Stevens & Lee

Presidential Memorandum Calls for Scrutiny and Fast-Track Repeal of Regulations

Stevens & Lee on

President Trump issued a Memorandum on April 6 directing the heads of all executive departments and agencies to identify on a fast-track basis (60 days) certain categories of “unlawful and potentially unlawful” regulations...more

McCarter & English, LLP

Texas District Court Vacates FDA’s Final Rule Expanding Oversight to Laboratory Tests in Hospitals

In our May 2024 Healthcare Alert, we discussed a final rule published by the US Food and Drug Administration (FDA) amending its regulations to include in vitro diagnostic products (IVDs), even those manufactured in a...more

Shipkevich PLLC

Connecticut Supreme Court Clarifies Attorney Exemption in Debt Negotiation Enforcement Action

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On April 8, 2025, the Connecticut Supreme Court, in Commonwealth Servicing Group, LLC v. Department of Banking, issued an opinion that only attorneys and law firms are permitted to claim the attorney exemption from the...more

Snell & Wilmer

Supreme Court Upholds ATF Rule Regulating Weapon Parts Kits and Unfinished Frames or Receivers as “Firearms”

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In a significant ruling, the Supreme Court affirmed the authority of the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) to regulate weapon parts kits and unfinished frames or receivers as “firearms” under the Gun...more

Vedder Price

The Mouse That Roared: A Look Back at TCW v. Evergreen

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The Federal Maritime Commission (the “FMC” or the “Commission”) recently issued its highly anticipated decision on remand in TCW, Inc. v. Evergreen Shipping Agency (America) Corp. et al. (the “Order on Remand”),[1] a...more

Troutman Pepper Locke

White House Issues Memorandum Directing Federal Agencies to Repeal Regulations Deemed to be Unlawful Pursuant to Recent U.S....

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On April 9, the White House issued a memorandum directing federal executive departments and agencies to repeal regulations deemed unlawful pursuant to certain U.S. Supreme Court decisions. This directive aims to address...more

Proskauer - Health Care Law Brief

Post‑Chevron Spotlight: Federal Court Nixes FDA Rule Reclassifying Laboratory Services as Medical Devices

In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the Food and Drug Administration’s (“FDA”) 2024 final rule that sought to bring...more

Wiley Rein LLP

Trump Directs Agencies to Quickly Repeal Unlawful Regulations, Without Notice-and-Comment

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On April 9, 2025, President Trump signed a Presidential Memorandum (Memorandum) entitled Directing the Repeal of Unlawful Regulations. The Memorandum – part of a broader “Department of Government Efficiency” Deregulatory...more

Sheppard Mullin Richter & Hampton LLP

Chief Justice Roberts Allows Trump to Remove Wilcox from NLRB as the Supreme Court Considers the Challenge to Her Dismissal

National Labor Relations Board (“NLRB”) Member Gwynne Wilcox is out of a job for the third time in less than four months. Since President Donald Trump terminated Wilcox from her position on January 28, 2025, Wilcox’s...more

Ropes & Gray LLP

District Court Embraces Loper Bright and Overturns FDA Laboratory Developed Test Rule – What Lies Ahead?

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On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA (“ACLA v. FDA”), a closely watched case...more

Constangy, Brooks, Smith & Prophete, LLP

On Again: Full D.C. Circuit sends Member Wilcox back to NLRB

The full U.S. Court of Appeals for the District of Columbia Circuit, in a 7-4 decision, has put Gwynne Wilcox (D), the on-again, off-again Member of the National Labor Relations Board, back on the Board. Member Wilcox, a...more

Faegre Drinker Biddle & Reath LLP

Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act

On March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in which FDA attempted to assert regulatory authority over laboratory-developed...more

Epstein Becker & Green

The LDT Final Rule Bites the Dust: Examining the Repercussions of the Federal Court’s Vacatur and What the Future May Hold

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory developed tests...more

Wilson Sonsini Goodrich & Rosati

FDA’s LDT Final Rule Rejected by Federal District Court in Texas

As Wilson Sonsini previously reported,1 the U.S. Food and Drug Administration (FDA) had been preparing the industry to comply with the 2024 LDT Final Rule, which phases out the FDA’s enforcement discretion policy for...more

McDermott Will & Emery

Detour Ahead: New Approach to Assessing Prior Art Rejections Under § 102(e)

The US Court of Appeals for the Federal Circuit established a more demanding test for determining whether a published patent application claiming priority to a provisional application is considered prior art under pre-America...more

Baker Donelson

HHS and HRSA Defend 340B Discount Model Against Pharma Rebate Plan

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Summary of Changes - In the fall of 2024, several pharmaceutical companies – specifically, Eli Lilly and Company, Sanofi-Aventis U.S. LLC, Bristol Myers Squibb Company, and Novartis Pharmaceuticals Corporation – reacted to...more

CDF Labor Law LLP

NLRB Again Without a Quorum

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Approximately three weeks ago, we reported that Judge Berly A. Howell, granted fired NLRB Board Member Gwynne A.Wilcox’s motion for summary judgment and reinstated her as a Board member. This decision restored the NLRB’s...more

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