Policy & Compliance

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  New draft guidance from the U.S. Food and Drug Administration provides formal insight on how drug manufacturers are expected to respond to Form 483s, raising some concerns about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 propety deed or a home, says Jonas McDavit at Spencer West.

• 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.

• 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.

• 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.

• A Shift In Fed. Circ.'s Approach To Patent Summary Judgment

  

  The Federal Circuit's recent decision in Range of Motion v. Armaid may come to be seen as a seminal opinion for potentially exposing and entrenching the Federal Circuit's movement away from its previous framework for identifying obvious noninfringement cases, says Nicholas Nowak at Nowak IP Group.

• DOJ Actions Suggest Expansion Of Healthcare Enforcement

  

  Recent actions by the U.S. Department of Justice and U.S. Food and Drug Administration suggest that federal healthcare enforcement efforts are moving away from traditional program-based fraud and toward cases centered on product integrity, regulatory transparency and telehealth marketing, effectively widening the government's enforcement playbook, say attorneys at MoFo.

• New Orphan Drug Law Provides A Key Fix For Pharma Cos.

  

  The Consolidated Appropriations Act enacted last month restores the U.S. Food and Drug Administration's long-standing interpretation of "same disease or condition," related to orphan drug exclusivity, resolving years of regulatory uncertainty and litigation that have discouraged rare disease research, say attorneys at Spencer Fane.

• FDA User Fee Talks Offer Clues On Upcoming Reforms

  

  As the U.S. Food and Drug Administration undergoes the User Fee Act reauthorization process and renegotiates its user fee agreements over the next several months, the agency's consultation meetings with relevant industries can shed light on the FDA's priorities, and provides stakeholders an opportunity to participate in the reform process, say attorneys at Holland & Knight.

• Changes Coming To The SBIR And STTR Programs

  

  Legislation recently approved by Congress to reauthorize the Small Business Innovation Research and Small Business Technology Transfer Programs includes changes focused on national security that would improve transparency but also increase applicants' administrative burdens, slow the awards process and likely increase litigation, say attorneys at Fluet & Associates.

• FDA Framework For Personalized Therapies Raises Questions

  

  The U.S. Food and Drug Administration's new plausible mechanism framework for developing individualized therapies reflects the agency's focus on rare-disease drugs, but numerous significant, unresolved issues cast uncertainty on how effective the framework will be in practice, say attorneys at Ropes & Gray.