Expert Analysis

• FDA Guidance May Move Goalposts For Form 483 Responses

  

  New draft guidance from the U.S. Food and Drug Administration provides formal insight on how drug manufacturers are expected to respond to Form 483s, raising some concerns about the agency's timelines and expectations, say attorneys at Cooley.

• 2 Strands Of Patent Law In High Court's 'Skinny Label' Case

  

  Amarin v. Hikma, which is set for oral argument in the U.S. Supreme Court this month, highlights the distinction between two different strands of intellectual property law — analogizing a patent to either a property deed or a home, says Jonas McDavit at Spencer West.

• Why MDLs Slow Down — And How To Speed Them Up

  

  Multidistrict litigation has become central to mass tort practice, but as MDLs grow in size and complexity, so do delays and costs — so tools like the new federal rule governing MDLs, targeted use of special masters and strategically deployed Lone Pine orders are more essential than ever, say attorneys at Ice Miller.

• A Check-Up On HHS' Push To Implement AI Infrastructure

  

  The U.S. Department of Health and Human Services has made some headway in its efforts to implement artificial intelligence across its agencies, but will have to overcome a number of near-term tests in order to be successful, says Theodore Thompson at Stinson.

• What A Court Doc Audit Reveals About Erroneous Filings

  

  My audit of 1,522 court documents from last month found that over 95% contained at least one verifiable error, with fewer than 1% showing clear indicators of artificial intelligence use — highlighting above all else that lawyers may want to focus most on strengthening their review processes, says Elliott Ash at ETH Zurich.

• Series

  Mich. Banking Brief: All The Notable Legal Updates In Q1

  

  Michigan's financial services sector saw several significant developments in 2026's first quarter, including the state Department of Insurance and Financial Services' issuance of a bulletin on the use of artificial intelligence and the Michigan House's introduction of a bill based on the Model Money Transmission Modernization Act, say attorneys at Dykema.

• The Road Ahead For Drug Development In The US

  

  Against the backdrop of drug manufacturers potentially looking to move development efforts overseas, the U.S. Food and Drug Administration's latest guidance on new approach methodologies signals the FDA is likely to be receptive to industry innovation that makes U.S.-based drug development faster or less expensive, creating opportunities and compliance risks for tech companies, say attorneys at Morgan Lewis.

• FDA's Crackdown On Drug Ads Conflicts With Precedent

  

  Recent U.S. Food and Drug Administration warning letters to drug manufacturers targeting direct-to-consumer advertising raise significant constitutional concerns, and directly clash with prior FDA stances, say attorneys at Sidley.

• Series

  Ultramarathons Make Me A Better Lawyer

  

  Completing a 100-mile ultramarathon was tougher, more humbling and more rewarding than I ever imagined, and the experience highlighted how long-distance running has sharpened my ability to adapt to the evolving nature of antitrust law and strengthened my resolve to handle demanding, unforeseen challenges, says Dan Oakes at Axinn.

• Determining When Engineered Biologics May Be Patentable

  

  The Federal Circuit's recent decision in Regenxbio v. Sarepta, concluding that engineered cells with DNA from different organisms are not patent-ineligible natural phenomena, raises questions surrounding what framework courts will use to evaluate the patent eligibility of engineered biologics moving forward, says Robert Frederickson at Goodwin.

• Informal Announcements Are Reshaping FDA Regulations

  

  The U.S. Food and Drug Administration's recent shift toward using press releases, podcasts and other informal channels to announce major policy changes reflects a valid desire to modernize and accelerate regulatory efforts, but it could lead to diminished transparency, increased industry burden and reduced policy durability, says Rachel Turow at Skadden.

• Getting The Most Out Of Learning And Development Programs

  Excerpt from Practical Guidance

  

  Junior associates can better develop the legal, business and interpersonal skills they need for long-term success by approaching their firms’ learning and development programs armed with five tips for getting the most out of these resources, says Lauren Hakala at Reed Smith.

• Opinion

  AI Presents A Make-Or-Break Moment For Outside Counsel

  

  The rapid adoption of artificial intelligence by corporate legal departments is forcing a long-overdue reset of the relationship between inside and outside counsel, and introducing a significant opportunity to shed frustrating inefficiencies and strengthen collaboration for firms willing to embrace the shift, says Intel Chief Legal Officer April Miller Boise.

• Opinion

  USPTO Has A Chance To Correct Double-Patenting Doctrine

  

  Now that the issue of obviousness-type double patenting is front and center before the U.S. Patent and Trademark Office's Appeals Review Panel, the agency should put an end to the practice of rejecting earlier-expiring patents in favor of later-expiring ones, say attorneys at Orrick.

• Navigating Life Sciences Deals Amid Heightened Scrutiny

  

  With pricing reform initiatives, national security legislation and evolving trade policy currently contributing to meaningful uncertainty for life sciences companies, it is important to proactively structure deals to avoid downstream complications, say attorneys at Cooley.