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Expert Analysis

• Takeaways From FDA's Updated Confirmatory Trial Guidance

  

  The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's intent to address the significant lag time between accelerated approval and full approval of drugs and may help motivate the industry to complete confirmatory trials, say attorneys at Sheppard Mullin.

• The Most Important Schedule I Drug Regulatory Shifts Of 2024

  

  In 2024, psychedelics and cannabis emerged as focal points in medical research, marking a pivotal year in their legal and regulatory journey, but these developments presented both opportunities and challenges within this evolving field, say Kimberly Chew at Husch Blackwell and Stephen Kim at Avicanna.

• Series

  Coaching Little League Makes Me A Better Lawyer

  

  While coaching poorly played Little League Baseball early in the morning doesn't sound like a good time, I love it 鈥� and the experience has taught me valuable lessons about imperfection, compassion and acceptance that have helped me grow as a person and as a lawyer, says Alex Barnett at DiCello Levitt.

• 5 Litigation Funding Trends To Note In 2025

  

  Lawyers and their clients must be prepared to navigate an evolving litigation funding market in 2025, made more complicated by a new administration and the increasing overall cost of litigation, says Jeffery Lula at GLS Capital.

• A Look At FDA's Plans To Establish New OTC Drug Category

  

  The U.S. Food and Drug Administration's recently finalized rule, creating a new over-the-counter pathway for drugs when patients satisfy certain conditions, may be useful for off-patent drugs with established safety records, though switching to OTC comes with additional costs and considerations, say attorneys at Skadden.

• The Fed. Circ. In 2024: 5 Major Rulings To Know

  

  In 2024, the Federal Circuit provided a number of important clarifications to distinct areas of patent law 鈥� including design patent obviousness, expert testimony admissions and patent term adjustments 鈥� all of which are poised to have an influence going forward, say attorneys at Knobbe Martens.

• Rethinking Litigation Risk And What It Really Means To Win

  

  Attorneys have a tendency to overestimate litigation risk before summary judgment and underestimate risk after it, but an eight-stage litigation framework can clarify risk at different points and help litigators reassess what true success looks like in any particular case, says Joshua Libling at Arcadia Finance.

• How DOGE's Bite Can Live Up To Its Bark

  

  All signs suggest that the Department of Government Efficiency will be an important part of the new Trump administration, with ample tools at its disposal to effectuate change, particularly with an attentive Republican-controlled Congress, say attorneys at K&L Gates.

• US-China Deal Considerations Amid Cross-Border Uncertainty

  

  With China seemingly set to respond to the incoming U.S. administration's call for strategic decoupling and tariffs, companies on both sides of the Pacific should explore deals and internal changes to mitigate risks and overcome hurdles to their strategic plans, say attorneys at Covington.

• Considering The Status Of The US Doctrine Of Patent Misuse

  

  A recent Ninth Circuit decision and a U.K. Court of Appeal decision demonstrate the impact that the U.S. Supreme Court's 2015 decision in Kimble v. Marvel Entertainment has had on the principle that post-patent-expiration royalty payments amount to patent misuse, not only in the U.S. but in English courts as well, say attorneys at Covington.

• Series

  Playing Rugby Makes Me A Better Lawyer

  

  My experience playing rugby, including a near-fatal accident, has influenced my legal practice on a professional, organizational and personal level by showing me the importance of maintaining empathy, fostering team empowerment and embracing the art of preparation, says James Gillenwater at Greenberg Traurig.

• Looking Back At 2024's Noteworthy State AG Litigation

  

  State attorneys general across the U.S. took bold steps in 2024 to address unlawful activities by corporations in several areas, including privacy and data security, financial transparency, children's internet safety, and other overall consumer protection claims, say attorneys at Troutman Pepper.

• Opinion

  No, Litigation Funders Are Not 'Fleeing' The District Of Del.

  

  A recent study claimed that litigation funders have 鈥渇led鈥� Delaware federal court due to a standing order requiring disclosure of third-party financing, but responsible funders have no problem litigating in this jurisdiction, and many other factors could explain the decline in filings, say Will Freeman and Sarah Tsou at Omni Bridgeway.

• Patent Policy Changes To Track Under New Gov't Leadership

  

  The new federal government will likely bring pivotal shifts in U.S. patent policy through legislation and initiatives that reflect a renewed focus on strengthening intellectual property rights, fostering innovation and enhancing the nation's competitive edge, says PK Chakrabarti at Butzel Long.

• Liability Risk For AI In Medical Devices Demands Greater Care

  

  As regulators push for legal reform surrounding artificial intelligence and cases implicating product liability for AI in medical technology continue to rise, manufacturers must adapt and implement new strategies to accommodate evolving risks, say attorneys at Crowell & Moring.