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.

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.

A Fed. Circ. Blueprint For Drafting Medical Device Patents

The Federal Circuit's decision in Constellation Designs v. LG last month, among other recent rulings, underscores the importance of emphasizing engineering, rather than clinical goals, when drafting patent claims for medical devices and software as a medical device, says Brandon Theiss at Volpe Koenig.

DTSA Data Shows Hidden Value Of Ex Parte Seizure Filings

Ten years of Defend Trade Secrets Act data indicate that although there is a low success rate for civil seizure applications, intellectual property litigators should continue filing them anyway in order to better their odds of obtaining other provisional relief, say attorneys at Reed Smith.

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.

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.

Startup Founder Disputes Increasingly Turn On Governance

Recent Delaware developments suggest that as courts place increasing emphasis on board process, independence and oversight in founder-led startups, the growing intersection of governance, technology risk and investor oversight is accelerating both the emergence and escalation of founder disputes, says mediator Frank Burke.

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.

Series

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.

How Del. Courts Will Likely Evaluate AI Oversight Claims

While no Delaware court has thus far adjudicated a claim based on alleged board failures to oversee artificial intelligence risk, recent Court of Chancery decisions suggest that familiar Caremark principles will be applied in predictable but consequential ways, particularly when AI touches mission‑critical operations, say attorneys at WilmerHale.

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.