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  The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's intent to address the significant lag time between accelerated approval and full approval of drugs and may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.

• UPS Penalty Demonstrates Goodwill Impairment Red Flags

  

  The U.S. Securities and Exchange Commission's recent $45 million penalty against UPS for withholding reports of goodwill impairment should warn investors to watch for the telltale signs of companies inflating their worth by delaying tests that would reveal similar declines in the value of intangible assets, say attorneys at Labaton Keller.

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  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 — 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.

• Courts Must Stick To The Science On Digital Addiction Claims

  

  A number of pending personal injury and product liability lawsuits allege that plaintiffs have developed behavioral addictions to the use of social media and video games — but this is not yet recognized by relevant authorities as an addiction, so courts must carefully scrutinize such claims, say attorneys at DLA Piper.

• 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.

• FTC Privacy Enforcement Takeaways From 2024

  

  In 2024, the Federal Trade Commission distinguished three prominent trends in its privacy-related enforcement actions: geolocation data protections, data minimization practices, and artificial intelligence use and marketing, say Cobun Zweifel-Keegan at IAPP and James Smith at Dechert.

• 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.

• Issues To Watch In 2025's ERISA Litigation Landscape

  

  Whether 2024’s uptick in new Employee Retirement Income Security Act cases will continue this year will likely depend on federal courts’ resolution of several issues, including those related to excessive fees, defined contribution plan forfeitures, and pleading standards for ERISA-prohibited transaction claims, say attorneys at Groom Law.

• 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.

• 2024 Was A Significant Year For HIPAA Compliance

  

  The Office of Civil Rights' high level of Health Insurance Portability and Accountability Act activity in 2024 and press releases about its specific focus on certain cybersecurity issues make it abundantly clear that the OCR is not going to tolerate widespread compliance complacency, says Nathan Kottkamp at Williams Mullen.

• 5 Notable Information Security Events In 2024

  

  B. Stephanie Siegmann at Hinckley Allen discusses 2024's largest and most destructive data breaches seen yet, ranging from ransomware disrupting U.S. healthcare systems on a massive scale, to tensions increasing between the U.S. and China over cyberespionage and the control of U.S. data.

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  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.

• How 2025 NDAA May Affect DOD Procurement Protests

  

  A bid protest pilot program included in the 2025 National Defense Authorization Act shifts litigation costs onto unsuccessful bid protesters and raises claim-filing thresholds, which could increase risks to U.S. Department of Defense contractors who file protests, and reduce oversight of DOD procurement awards, say attorneys at Venable.

• 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.