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  New draft guidance from the U.S. Food and Drug Administration provides formal insight on how drug manufacturers are expected to respond to Form 483s, raising some concerns about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.

• Telehealth Suit May Redraw Rules For Physician Classification

  

  A new class action in California federal court, Cioppettini v. Mochi Medical, alleging a telehealth company misclassified providers as independent contractors, suggests that traditional markers of physician independence may not apply to telehealth, say attorneys at Reed Smith.

• Legal Theories In Social Media Verdicts Hold Clues On Impact

  

  Although the two verdicts in cases in New Mexico and California involving Meta and Google are being lumped together, they rest on fundamentally different legal theories, and that distinction determines how their effects may be felt in other jurisdictions, says Mark Morgan at Day Pitney.

• Senior Housing Demands A Distinct Dealmaking Playbook

  

  An aging population and evolving state regulations underscore a critical reality that senior housing assets can undergo operational or compliance shifts during dealmaking, highlighting the need for unique contractual safeguards like expanded disclosures, anchored notice obligations, and targeted closing conditions and remedies, say attorneys at Goodwin.

• 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.

• Exploring When Fraud Asset Freezes Limit Right To Pick Atty

  

  The defendant’s claim in the Seventh Circuit’s pending U.S. v. Shah case that the government restrained his assets until he couldn’t afford his chosen counsel presents a useful case study in how criminal forfeiture procedure interacts with U.S. Supreme Court rulings on Sixth Amendment rights and appealing complex fraud convictions, says Elisha Kobre at Sheppard.

• Similar-Looking Designs May Not Always Prove Infringement

  

  The Federal Circuit's recent decision in Range of Motion Products v. Armaid is a reminder that even a strikingly similar design might not be found to infringe upon a patented design once design features driven by functionality are filtered out from consideration, say attorneys at BCLP.

• 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.