Expert Analysis

• 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.

• Tracking Tech Suit Is A Risk Management Reminder For Cos.

  

  The Fifth Circuit recently heard oral argument in Rand v. Eyemart Express — an appeal that could reshape the legal landscape for businesses that deploy tracking tech on their websites — underscoring the importance of proactive risk management for companies across multiple industries, say attorneys at Blank Rome.

• 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.

• 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.

• AI Regulatory Gaps May Fuel FCA Enforcement Action

  

  The intersection of artificial intelligence and False Claims Act enforcement presents legal risk for government contractors across several industries, particularly in the absence of a federal regulatory framework explicitly governing its development and use, say attorneys at O’Melveny.

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  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.

• 3 AI Adoption Mistakes GCs Should Avoid

  

  The pressure in-house legal teams face to quickly adopt artificial intelligence tools, combined with budget constraints and the need to evaluate a crowded market of options, sets the stage for implementation mistakes that are often difficult to undo, says former 23andMe general counsel Guy Chayoun.

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  Playing Basketball Makes Me A Better Lawyer

  

  My grandfather used to say "I wear your jersey" as shorthand for wholly committing to support someone with loyalty and integrity — ideals that have shaped my life on the basketball court and in legal practice, says Tracy Schimelfenig at Schimelfenig Legal.

• EPA Listing Signals New Scrutiny Of Drugs In Drinking Water

  

  The recent publication of the U.S. Environmental Protection Agency's latest draft drinking water contaminant list highlights pharmaceuticals as a category of concern, marking the start of a process that could shape future research priorities, monitoring requirements, and federal and state actions, say attorneys at Morgan Lewis.

• Opinion

  5th Circ.'s Abortion Pill Order Is Shaky On Multiple Grounds

  

  The Fifth Circuit's recent order in Louisiana v. U.S. Food and Drug Administration, reinstating an in-person dispensing requirement for the abortion medication mifepristone, seems to turn federalism upside-down, and is also questionable for several other reasons, says Gregory Curtner at Curtner Law.

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  The Biz Court Digest: Georgia Court Has Business On Its Mind

  

  Thanks to recent legislation, the Georgia State-wide Business Court will soon offer business litigants greater access to the court than ever before, further enhancing the court's emphasis on efficiency, predictability and accessibility for sophisticated commercial disputes, says former GSBC judge Walt Davis at Jones Day.

• 5 Takeaways From Justices' Subpoena Fight Ruling

  

  The U.S. Supreme Court's recent decision in First Choice v. Davenport fortifies a line of First Amendment associational privacy cases stretching back nearly 70 years, and ensures that organizations subject to government demands for donor information have a meaningful federal forum in which to defend their constitutional rights, say attorneys at DLA Piper.

• Mass. Draft Regs Signal Nationwide Scrutiny Of Junk Fees

  

  Massachusetts Attorney General Andrea Campbell's new draft regulations for assisted living facilities is only her latest move in the war on junk fees — and part of a national reordering of consumer protection enforcement in which states are aggressively and creatively asserting authority, says Steve Provazza at Arnall Golden.