Engaging With FDA's New Complete Response Letter Policy

A citizen petition filed with the U.S. Food and Drug Administration last month puts renewed focus on the agency's practice of releasing complete response letters in near real time, materially altering the context in which life sciences companies communicate with investors regarding regulatory developments, say attorneys at Debevoise.

Data Center Developer Lessons From Maine's Vetoed Ban

The regulatory and political dynamics that recently led Maine’s governor to veto a popular bipartisan bill proposing a temporary data center development ban offer a useful template that developers can use to help their projects survive other states' attempts at moratoriums, say attorneys at Thompson Hine.

Revised Fed Principles Balance Risk And Remediation

The Federal Reserve's recently updated supervisory principles sharpen standards for enforcement actions while rewarding self-identification and remediation, signaling a more transparent approach that could reduce uncertainty and reshape how banks manage examination risk and regulator engagement going forward, say attorneys at Davis Wright.

Big Issues Linger After Senate Prediction Market Trading Ban

Whether the Senate can — or should — extend prediction market trading restrictions beyond itself will test not only the boundaries of insider trading law, but also the structural limits of legislative power in an era where information itself has become a tradable asset, say attorneys at Benesch.

Series

Law School's Missed Lesson: Diagnose Before Arguing

Law school often skips over explicitly teaching students how to determine what kind of problem a case presents before they commit to a particular doctrinal path, which risks building arguments that are internally coherent but externally misaligned, says Melanie Oxhorn at Kobre & Kim.

Trump's Psychedelics EO Creates A Regulatory Collision

Sponsors pursuing U.S. Food and Drug Administration approval for psychedelic drug access must tackle how to generate regulatory-grade safety and efficacy data in controlled trials when President Donald Trump's recent executive order on psychedelics mandates uncontrolled access through Right to Try, say Kimberly Chew at Husch Blackwell and Odette Hauke at Odette Alina.

What Model Risk Guidance Update Means For Banks

Federal prudential regulators recently issued new model risk management guidance for banks that is designed to reduce prescriptive supervisory expectations and instead focus more on material financial risk, so banking organizations should reassess their model inventories, apply the new materiality framework and update their internal policies, say attorneys at Orrick.

Recent Benchmarking Suits Highlight DOJ Enforcement Risks

The U.S. Department of Justice's recent settlements with RealPage and Agri Stats inform the level of antitrust risk surrounding the use of benchmarking services and suggest an aggressive enforcement approach, particularly with respect to granular data and nonprice data reporting, say attorneys at Axinn.

Becoming The Biz-Savvy GC That Portfolio Companies Need

Candidates for general counsel roles at private equity-backed portfolio companies should prioritize proving their sector-specific experience, commercial judgment and ease with uncertainty — and attorneys hoping to be candidates in five to 10 years should start working on those skills now, says Dimitri Mastrocola at Major Lindsey.

Operational AI Washing: The Section 220 Information Strategy

Plaintiffs filing AI washing claims will likely use Section 220 of the Delaware General Corporation Law to obtain internal board records, but 2025 amendments have fundamentally changed the landscape of presuit shareholder document demands in ways that create both risk and opportunity for companies, say attorneys at Akerman.

What New PFAS Rule Means For Tracking And Disclosure

In the wake of the U.S. Environmental Protection Agency's publication of its rule adding PFHxS-Na to the Toxics Release Inventory, companies should identify this substance in their facilities and supply chains, and prepare for disclosures to both regulators and the public, says Ayodeji Ayolola at Gordon Rees.

Ch. 11 Ruling Raises Bar For Avoiding Default Interest

Following a New York bankruptcy court's recent decision in 33 Mako, solvent debtors may find it significantly harder to avoid paying contractual default interest to oversecured lenders under Section 506(b) of the Bankruptcy Code, say attorneys at Benesch.

Series

Judges On AI: How Courts Can Survive The Tech Revolution

Colorado Supreme Court Justice Maria Berkenkotter and Colorado Court of Appeals Judge Lino Lipinsky de Orlov discuss how artificial intelligence has already fundamentally altered the legal system and offer tips for courts navigating deepfakes, hallucinations and a gap in access to AI tools.

'Skinny Label' Arguments Spotlight Induced Infringement Risk

Recent oral arguments before the U.S. Supreme Court in Hikma Pharmaceuticals v. Amarin Pharma highlight the uncertain boundary between lawful generic competition through so-called skinny labels and induced patent infringement, with potential implications for patent holders’ communication, enforcement and causation strategies across industries, says Anton Hopen at Trenam.

What Jury Holdouts Can Teach Trial Lawyers About Strategy

Though a hung jury can be a disappointment, a psychological understanding of jury holdouts can help trial lawyers shape their damages arguments and understand leadership and group composition as a function of jury selection, says Clint Townson at Townson Litigation.