Expert Analysis

• FDA's AI Deployment Brings New Potential And Risks

  

  The U.S. Food and Drug Administration's recent announcement about making agentic artificial intelligence tools available to agency employees may portend accelerated regulatory timelines and lower costs for drug companies and consumers, but potential errors and biases will necessitate additional safeguards, says Angela Silva at Lewis Brisbois.

• 3 Key Takeaways From Planned Rescheduling Of Cannabis

  

  An executive order reviving cannabis rescheduling represents a monumental change for the industry and, while the substance will remain illegal at the federal level, introduces several benefits, including improving state-legal cannabis operators' tax treatment, lowering the industry's legal risk profile, and leaving state-regulated markets largely intact, say attorneys at Dentons.

• 6 Issues That May Follow The 340B Rebate Pilot Challenge

  

  Though the Health Resources and Services Administration withdrew a pending case to reconsider the controversial 340B rebate pilot program, a number of crucial considerations remain, including the likelihood of a rework and questions about what that rework might look like, say attorneys at Spencer Fane.

• 5 E-Discovery Predictions For 2026 And Beyond

  

  2026 will likely be shaped by issues ranging from artificial intelligence regulatory turbulence to potential evidence rule changes, and e-discovery professionals will need to understand how to effectively guide the responsible and defensible adoption of emerging tools, while also ensuring effective safeguards, say attorneys at Littler.

• Streamlining Product Liability MDLs With AI And Rule 16.1

  

  With newly effective Rule 16.1 of the Federal Rules of Civil Procedure providing enhanced guidance on multidistrict litigation and the sophistication of artificial intelligence continuing to advance, parties have the opportunity to better confront the significant data challenges presented by product liability MDLs, say attorneys at Hollingsworth.

• Business Considerations Amid Hemp Product Policy Change

  

  With the passage of a bill fundamentally narrowing the federal definition of "hemp," there are practical and business considerations that brands, manufacturers and other parties should heed over the next year, including operational strategies, evaluating contract and counterparty risk, and tax implications, say attorneys at Foley Hoag.

• Series

  Judges On AI: How Courts Can Boost Access To Justice

  

  Arizona Court of Appeals Judge Samuel A. Thumma writes that generative artificial intelligence tools offer a profound opportunity to enhance access to justice and engender public confidence in courts’ use of technology, and judges can seize this opportunity in five key ways.

• Fed. Circ. In November: Looking For Patent 'Blaze Marks'

  

  The Federal Circuit's recent decision in Duke v. Sandoz serves as a warning that when patentees craft claims, they must provide adequate "blaze marks" that direct a skilled artisan to the specific claimed invention, and not just the individual claimed elements in isolation, say attorneys at Knobbe Martens.

• 2025's Most Notable State AG Activity By The Numbers

  

  State attorneys general were active in 2025, working across party lines to address federal regulatory gaps in artificial intelligence, take action on consumer protection issues, continue antitrust enforcement and announce large settlements on behalf of their citizens, say attorneys at Jenner & Block.

• Opinion

  The Case For Emulating, Not Dividing, The Ninth Circuit

  

  Champions for improved judicial administration should reject the unfounded criticisms driving recent Senate proposals to divide the Ninth Circuit and instead seek to replicate the court's unique strengths and successes, says Ninth Circuit Judge J. Clifford Wallace.

• How Rule 16.1 Streamlines And Validates Mass Tort Litigation

  

  The new Rule 16.1 of the Federal Rules of Civil Procedure not only serves a practical purpose by endorsing early, structured case management and dispositive motion practice in multidistrict litigation, but also explicitly affirms the importance of MDL practice in the justice system, says Rocco Strangio at Milestone.

• How 11th Circ.'s Zafirov Decision Could Upend Qui Tam Cases

  

  Oral argument before the Eleventh Circuit last month in U.S. ex rel. Zafirov v. Florida Medical Associates suggests that the court may affirm a lower court's opinion that the qui tam provisions of the False Claims Act are unconstitutional — which could wreak havoc on pending and future qui tam cases, say attorneys at Morgan Lewis.

• Key Trends For Life Sciences Cos. To Watch In 2026

  

  Following a year of drastic change at the U.S. Food and Drug Administration, two themes are likely to drive the coming year — a commitment to lowering the cost of drugs and an inherent tension between the priorities of the health agencies and the broader administration, say attorneys at Sheppard Mullin.

• Series

  Muay Thai Makes Me A Better Lawyer

  

  Muay Thai kickboxing has taught me that in order to win, one must stick to one's game plan and adapt under pressure, just as when facing challenges by opposing counsel or judges, says Mark Schork at Feldman Shepherd.

• The Next Pressure Point In Digital Health: Informed Consent

  

  Two new federal digital health initiatives will usher in a new era where virtual care, software-enabled devices and home-based monitoring are integrated into care and reimbursement models, with the impact of shifting rules and opportunities felt most immediately in the context of informed consent, says Kimberly Chew at Husch Blackwell.