Expert Analysis

• 5 Open Questions About FDA's AI-Assisted Review Plans

  

  The U.S. Food and Drug Administration recently touted the completion of a generative artificial intelligence program for scientific reviewers and plans for agencywide deployment to speed up reviews of premarket applications, but there is considerable uncertainty surrounding the tools' ability to protect trade secrets, avoid bias and more, say attorneys at King & Spalding.

• How Trump Administration's Antitrust Agenda Is Playing Out

  

  Under the current antitrust agency leadership, the latest course in merger enforcement, regulatory approach and key sectors shows a marked shift from Biden-era practices and includes a return to remedies and the commitment to remain focused on the bounds of U.S. law, say attorneys at Wilson Sonsini.

• Attacks On Judicial Independence Tend To Manifest In 3 Ways

  

  Attacks on judicial independence now run the gamut from gross (bald-faced interference) to systemic (structural changes) to insidious (efforts to undermine public trust), so lawyers, judges and the public must recognize the fateful moment in which we live and defend the rule of law every day, says Jim Moliterno at Washington and Lee University.

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  Law School's Missed Lessons: Appreciating Civil Procedure

  

  If you’re like me, law school’s often complex and theoretical approach to teaching civil procedure may have contributed to an early struggle with the topic, but when seen from a practical perspective, new lawyers may find they enjoy mastering these rules, says Chloe Villagomez at Foster Garvey.

• Calif. Bar Exam Fiasco Shows Why Attys Must Disclose AI Use

  

  The recent revelation that a handful of questions from the controversial California bar exam administered in February were drafted using generative artificial intelligence demonstrates the continued importance of disclosure for attorneys who use AI tools, say attorneys at Troutman.

• What Parity Rule Freeze Means For Plan Sponsors

  

  In light of a District of Columbia federal court’s recent decision to stay litigation challenging a Mental Health Parity and Addiction Equity Act final rule, as well as federal agencies' subsequent decision to hold off on enforcement, attorneys at Morgan Lewis discuss the statute’s evolution and what plan sponsors and participants can expect going forward.

• In 2nd Place, Va. 'Rocket Docket' Remains Old Reliable

  

  The U.S. District Court for the Eastern District of Virginia was again one of the fastest civil trial courts in the nation last year, and an interview with the court’s newest judge provides insights into why it continues to soar, says Robert Tata at Hunton.

• What FCA Liability Looks Like In The Cybersecurity Realm

  

  ​Two recent settlements highlight how whistleblowers and the U.S. Department of Justice have been utilizing the False Claims Act to allege fraud predicated on violations of cybersecurity standards — timely lessons given new bipartisan legislation introducing potential FCA liability for artificial intelligence use, say​ attorneys Rachel Rose and Julie Bracker.

• How Attorneys Can Become Change Agents For Racial Equity

  

  As the administration targets diversity, equity and inclusion efforts and law firms consider pulling back from their programs, lawyers who care about racial equity and justice can employ four strategies to create microspaces of justice, which can then be parlayed into drivers of transformational change, says Susan Sturm at Columbia Law School.

• CMS Guidance May Complicate Drug Pricing, Trigger Lawsuits

  

  Recent draft guidance from the Centers for Medicare & Medicaid Services proposes to expand the scope of what counts as the same qualifying single-source drug, which would significantly alter the timeline for modified drugs facing price controls and would likely draw legal challenges from innovator drug companies, say attorneys at Debevoise.

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  Running Marathons Makes Me A Better Lawyer

  

  After almost five years of running marathons, I’ve learned that both the race itself and the training process sharpen skills that directly translate to the practice of law, including discipline, dedication, endurance, problem-solving and mental toughness, says Lauren Meadows at Swift Currie.

• 3 Takeaways From Recent Cyberattacks On Healthcare Cos.

  

  For the healthcare industry, the upward trend in styles of cyberattacks, costs, and entities targeted highlights the critical importance of proactive planning to help withstand the operational, legal and reputational turmoil that can follow a data breach, say attorneys at Troutman Pepper.

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  Law School's Missed Lessons: Supporting A Trial Team

  

  While students often practice as lead trial attorneys in law school, such an opportunity likely won’t arise until a few years into practice, so junior associates should focus on honing skills that are essential to supporting a trial team, including organization, adaptability and humility, says Lucy Zelina at Tucker Ellis.

• FAR Rewrite May Cloud Key Gov't Contract Doctrine

  

  The Trump administration's government procurement overhaul, under which sections of the Federal Acquisition Regulation are eliminated by default, is bound to collide with a doctrine that allows courts to read omitted clauses into government contracts if they represent long-standing pillars of federal procurement law, say attorneys at Rogers Joseph.

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  Adapting To Private Practice: From US Attorney To BigLaw

  

  When I transitioned to private practice after government service — most recently as the U.S. attorney for the Eastern District of Virginia — I learned there are more similarities between the two jobs than many realize, with both disciplines requiring resourcefulness, zealous advocacy and foresight, says Zach Terwilliger at V&E.