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  The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's intent to address the significant lag time between accelerated approval and full approval of drugs and may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

• Key Trends In PFAS Regulation And Litigation For 2025

  

  The critical policy milestones for per- and polyfluoroalkyl substances expected in 2025 will not only shape the trajectory of PFAS regulation, but also set key precedents for environmental accountability, potentially reshaping the corporate approach to these "forever chemicals" for decades to come, say attorneys at MG+M.

• Inside New Commerce Tech Restrictions: Key Risk Takeaways

  

  While there are a few limitations on the scope of a new final rule restricting certain foreign adversary products and technologies, the Commerce Department's Bureau of Industry and Security retains sweeping authority to regulate an array of risk areas, says Peter Jeydel at Troutman.

• 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.

• California's New Homeowner Law Could Hamper Foreclosures

  

  While A.B. 2424, which took effect this month in California, gives homeowners in default additional protections, it also provides loopholes that can be used to delay foreclosure auctions, and the cost of these delays will likely be passed on to the borrower, says Stephen Britt at Severson & Werson.

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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.

• How Fintechs Can Respond To New CFPB Supervisory Rule

  

  Even though a new Consumer Financial Protection Bureau rule pulling large payment apps into supervision faces an uncertain fate in the new administration, providers should still examine the rule's definitions and prepare for increased compliance costs and more consumer-friendly practices, say attorneys at DLA Piper.

• Ruling Shows High Court Willing To Limit Immigration Review

  

  The U.S. Supreme Court's recent decision in Bouarfa v. Mayorkas is the latest demonstration of the court’s readiness to limit judicial review in the immigration space, a notable break from other recent decisions that expanded judicial review of agency decisions in other areas, says Mark Fleming at WilmerHale.

• 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.

• Despite Political Divide, FEC Found Common Ground In '24

  

  The Federal Election Commission, although evenly split between Republicans and Democrats, reached consensus in consequential advisory opinions, enforcement actions and regulations last year, offering welcome clarity on some key questions facing campaigns, PACs and parties, say attorneys at Covington.

• How FTC Sent A $5.6M Warning Against Jumping The Gun

  

  The Federal Trade Commission's recent record $5.6 million "gun jumping" action against Verdun Oil, for allegedly exerting control over EP Energy before the mandatory waiting period under U.S. antitrust law expired, warns companies that they must continue to operate independently during review, say attorneys at Ballard Spahr.

• How Deregulation Could Undermine Trump's Anti-DEI Agenda

  

  While rolling back federal agency power benefited conservative policies during the Biden administration, it will likely undermine President Donald Trump's ability to wield agencies like the U.S. Equal Employment Opportunity Commission to dismantle diversity, equity and inclusion initiatives beyond the federal workforce and into the private sector, says Ally Coll at the Purple Method.

• Managing Litigation Side-Switching During 2nd Trump Admin

  

  Now that the new presidential administration is in place, the government will likely switch positions in a number of pending cases, and stakeholders should employ strategies to protect their interests, say attorneys at Covington.

• A Look At Sweepstakes Casinos' Legal Issues In Fla., Beyond

  

  Scheduled for trial in Florida federal court this fall, the VGW sweepstakes case underscores the growing urgency for gambling states to clarify and enforce their laws in response to emerging online gaming models, as the expansion of sweepstakes casinos challenges traditional interpretations of gambling regulations, say attorneys at Holland & Knight.

• 3 Noteworthy Effects Of The 2025 NDAA

  

  The 2025 defense budget includes further restrictions on semiconductor sales to Huawei, requiring companies to rethink customer-base oversight, but other provisions are likely to broaden procurement contract opportunities, say attorneys at Miles & Stockbridge.