Expert Analysis

• A Potential Shift In FDA's Approach To Drug Trial Design

  

  Recent guidance released by the U.S. Food and Drug Administration clarifying how Bayesian approaches — which combine prior knowledge with new data — may be used in clinical trials reflects the agency's continued interest in innovative trial designs that may accelerate drug approvals, say attorneys at Alston & Bird.

• Series

  Trivia Competition Makes Me A Better Lawyer

  

  Playing trivia taught me to quickly absorb information and recognize when I've learned what I'm expected to know, training me in the crucial skills needed to be a good attorney, and reminding me to be gracious in defeat, says Jonah Knobler at Patterson Belknap.

• What FDA Guidance Means For Future Of Health Software

  

  Two significant final guidance documents released by the U.S. Food and Drug Administration last month reflect a targeted effort to ease innovation friction around specific areas, including singular clinical decision support recommendations and sensor-based wearables, while maintaining established regulatory boundaries, say attorneys at Covington.

• Opinion

  Federal Preemption In AI And Robotics Is Essential

  

  Federal preemption offers a unified front at a decisive moment that is essential for safeguarding America's economic edge in artificial intelligence and robotics against global rivals, harnessing trillions of dollars in potential, securing high-skilled jobs through human augmentation, and defending technological sovereignty, says Steven Weisburd at Shook Hardy.

• Series

  Law School's Missed Lessons: What Cross-Selling Truly Takes

  

  Early-career attorneys may struggle to introduce clients to practitioners in other specialties, but cross-selling becomes easier once they know why it’s vital to their first years of practice, which mistakes to avoid and how to anticipate clients' needs, say attorneys at Moses & Singer.

• Drafting Tech Patents After USPTO's Eligibility Memos

  

  Two recent U.S. Patent and Trademark Office memos on subject matter eligibility declarations provide an evidentiary playbook for artificial intelligence and software patent applications, highlighting how targeted, stand‑alone SMEDs that present objective, claim‑anchored facts can improve patent application outcomes, say attorneys at Reed Smith.

• How State FCA Activity May Affect Civil Fraud Enforcement

  

  A growing trend of state attorneys general enforcing their False Claims Act analogues independently of the U.S. Department of Justice carries potential repercussions for civil fraud enforcement and qui tam litigation considerations, say Li Yu at Bernstein Litowitz, Ellen London at London & Naor and Gwen Stamper at Vogel Slade.

• Series

  Judges On AI: Practical Use Cases In Chambers

  

  U.S. Magistrate Judge Allison Goddard in the Southern District of California discusses how she uses generative artificial intelligence tools in chambers to make work more efficient and effective — from editing jury instructions for clarity to summarizing key documents.

• Assessing Compliance Risks Around TrumpRx Participation

  

  As there are novel compliance obligations and potential political opposition related to the new TrumpRx online drug platform, companies intending to participate on the site should consider the pressure points that are likely to draw enforcement scrutiny, say attorneys at Sheppard.

• USPTO Initiatives May Bolster SEP Litigation In The US

  

  The U.S. Patent and Trademark Office's recent efforts to revitalize standard-essential patent litigation face hurdles in their reliance on courts and other agencies, but may help the U.S. regain its central role in global SEP litigation if successful, say attorneys at Axinn.

• Series

  Trail Running Makes Me A Better Lawyer

  

  Navigating the muddy, root-filled path of trail marathons and ultramarathons provides fertile training ground for my high-stakes fractional general counsel work, teaching me to slow down my mind when the terrain shifts, sharpen my focus and trust my training, says Eric Proos at Next Era Legal.

• Predicting Actual Impact From CDC's New Vaccine Guidance

  

  Recent federal changes to the childhood immunization schedule, reducing the number of vaccine recommendations from 18 to 11, do not automatically create enforceable obligations for parents, schools or healthcare providers, but may spur litigation and other downstream effects on school policies and state guidelines, says Mehdi Sinaki at Michelman & Robinson.

• AI Scientific Discovery Order Implications For Life Sciences

  

  President Donald Trump's November executive order establishing a government effort to use artificial intelligence to accelerate scientific discovery has the potential to leverage significant federal resources and data to support research, drug and device approvals, and AI model training in the life sciences sector, say attorneys at Hogan Lovells.

• What Rescheduling Means For Cannabis Labels, Marketing

  

  The proposed reclassification of cannabis is expected to bring heightened scrutiny of labeling, advertising and marketing from the U.S. Food and Drug Administration and the Federal Trade Commission, but the brands that tighten evidence, standardize operations and professionalize marketing controls now will see fewer surprises and better outcomes, say attorneys at Wilson Elser.

• Tips From Del. Decision Nixing Major Earnout Damages Award

  

  The Delaware Supreme Court recently vacated in part the largest earnout-related damages award in Delaware history, making clear that the implied covenant of good faith and fair dealing cannot be used to rescue parties from drafting choices where the relevant regulatory risk was foreseeable at signing, say attorneys at Sullivan & Cromwell.