Expert Analysis

• Pros And Cons Of FDA's Push For Nonprescription Drugs

  

  The U.S. Food and Drug Administration's recent moves to shift more prescription drugs to over-the-counter status could increase access to important medications, but also bring potential safety risks and other trade-offs for drug companies, say attorneys at Hogan Lovells.

• Why SDNY May Be Dusting Off The Financial Kingpin Statute

  

  The Southern District of New York’s recent fraud indictments against executives of bankrupt companies Tricolor and First Brands have seemingly revived the Continuing Financial Crimes Enterprise statute, and if the cases succeed, prosecutors across the country will have ample reason to reach for this long-dormant tool, say attorneys at Lankler Siffert & Wohl.

• What's Changed In Army Corps' Reissued Nationwide Permits

  

  The final rule recently issued by the U.S. Army Corps of Engineers, renewing and revising nationwide permits for projects covered by Section 404 of the Clean Water Act, makes measured adjustments rather than sweeping revisions, addressing key operational and compliance concerns while maintaining the existing framework, say attorneys at Spencer Fane.

• What Kalshi Cases Reveal About State Authority, Regulation

  

  Prediction markets like Kalshi have ignited complex legal battles that get to the heart of how novel financial products intersect with traditional state enforcement authority, and courts are already beginning to divide over whether federal law preempts state enforcement authority restricting these offerings, say attorneys at Holtzman Vogel.

• Parsing Clarifications On Foreign Entity Rules For Tax Credits

  

  Recent U.S. Internal Revenue Service and Treasury Department guidance answers taxpayer questions on several key foreign entity rules under the One Big Beautiful Bill Act, but questions remain over transactions with companies that have ties to covered nations such as Iran, say attorneys at Cleary.

• What US Arms Sales Reforms Mean For Defense Industry

  

  A recent executive order with the goal of increasing U.S. arms sales transparency, speed and government-industry collaboration carries both promise and risk for the defense industry as the government seeks to leverage the private sector and use commercial products for defense purposes, say attorneys at Fluet.

• Prepping For The Future Of No Surprises Act Enforcement

  

  This year is expected to be a transition point for the No Surprises Act framework from regulatory delay to operational enforcement, so stakeholders should use this time to stress-test systems, clean up processes and prepare for enforcement, say attorneys at Akerman.

• A Tale Of 2 Self-Disclosure Policies: How SDNY, DOJ Differ

  

  Though the U.S. Attorney’s Office for the Southern District of New York’s recently announced corporate enforcement and voluntary self-disclosure policy shares many similarities with that of the U.S. Department of Justice, the two programs differ in meaningful ways, including subject matter scope and timeline to declination, say attorneys at Wiley.

• Aligning Microsoft Tools With NYC Bar AI Recording Guidance

  

  The New York City Bar Association’s recently issued formal opinion, providing ethical guidance on artificial intelligence-assisted recording, transcription and summarization, raises immediate questions about data governance and e-discovery for companies that use Microsoft 365 and Copilot, say Staci Kaliner, Martin Tully and John Collins at Redgrave.

• What Employers Should Know About Calif. PAGA Proposal

  

  Recently proposed regulations concerning the Private Attorneys General Act evidence an intent by California's Labor and Workforce Development Agency to play a greater role in the prosecution of PAGA actions, including more oversight over the exhaustion notices and settlement process, say attorneys at Paul Hastings.

• FTC Focus: Antitrust Spotlight On 'Acqui-Hires,' Noncompetes

  

  A recent Federal Trade Commission focus on labor issues, like 'acqui-hire' deals, in which only a company's workforce is acquired, and noncompetes, shows that the agency is scrutinizing these issues on a case-by-case basis, necessitating a meaningful look at these transactions, particularly in the technology and artificial intelligence industries, say attorneys at Proskauer.

• FDA's Biosimilarity Guidance Holds Uncertain Implications

  

  The U.S. Food and Drug Administration's new draft guidance aimed at simplifying the biosimilarity demonstration process may not be enough to overcome the barriers that have historically constrained biosimilar competition, and could affect biosimilar access in unexpected ways, say analysts at Analysis Group.

• Unpacking Key Themes From NY's New Healthcare Strategy

  

  New York Gov. Kathy Hochul's 2026 State of the State agenda, read together with the state's fiscal year 2027 executive budget, reflect a clear framework to utilize Medicaid as the state's operating platform for healthcare reform, say attorneys at Sheppard.

• A Single DOJ Corporate Enforcement Policy Raises Questions

  

  The U.S. Department of Justice's soon-to-be-released uniform corporate criminal enforcement policy could address the challenges raised by the current decentralized approach, but it will need to answer a number of potential questions amid scant details, say attorneys at Pillsbury.

• WTO Most‑Favored‑Nation Reform May Hold Promise

  

  When the World Trade Organization meets this month, it is expected to debate changing the most-favored-nation rule, a carefully calibrated loosening of which may be justified if it enables deeper liberalization and regulatory cooperation, says Alan Yanovich at Akin.