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Expert Analysis

• Prepare For Increased FDA Inspections Of Foreign Facilities

  

  In light of the U.S. Food and Drug Administration's recently announced plans to expand use of unannounced inspections of foreign drug manufacturing factories, foreign firms should implement best practices in anticipation of an imminent increase in enforcement activity, say attorneys at McGuireWoods.

• Series

  Â鶹´«Ã½ School's Missed Lessons: Teaching Yourself Legal Tech

  

  New graduates often enter practice unfamiliar with even basic professional software, but budding lawyers can use on-the-job opportunities to both catch up on technological skills and explore the advanced legal and artificial intelligence tools that will open doors, says Alyssa Sones at Sheppard Mullin.

• Opinion

  Legacy Of 3 Justices Should Guide Transgender Rights Ruling

  

  Three Republican-appointed U.S. Supreme Court justices — Anthony Kennedy, Sandra Day O'Connor and David Souter — gave rise to a jurisprudence of personal liberty that courts today invoke to protect gender-affirming care, and with the court now poised to decide U.S. v. Skrmetti, it must follow the path that they set, says Greg Fosheim at McDermott.

• How AI May Reshape The Future Of Adjudication

  

  As discussed at a recent panel at Texas A&M, artificial intelligence will not erase the human element of adjudication in the next 10 to 20 years, but it will drive efficiencies that spur private arbiters to experiment, lead public courts to evolve and force attorneys to adapt, says Christopher Seck at Squire Patton.

• When Legal Advocacy Crosses The Line Into Incivility

  

  As judges issue sanctions for courtroom incivility, and state bars advance formal discipline rules, trial lawyers must understand that the difference between zealous advocacy and unprofessionalism is not just a matter of tone; it's a marker of skill, credibility and potentially disciplinary exposure, says Nate Sabri at Perkins Coie.

• How Medical Practices Can Improve Privacy Compliance

  

  In light of recent high-profile patient privacy violations, health practices — especially in California — should better position themselves to comply with medical privacy laws by shoring up strategies ranging from mapping electronic protected health information to building a better compliance culture, says Suzanne Natbony at Aliant Â鶹´«Ã½.

• Recent Reports Shed Light On Section 340B's Effectiveness

  

  Recent analyses of the Section 340B program's effectiveness in helping patients afford drugs in Minnesota reinforce concerns about the program's lack of transparency and underscore the need for further evaluation of whether legislative reform should be enacted, say William A. Sarraille at the University of Maryland, and Andrée-Anne Fournier and Molly Frean at Analysis Group.

• Series

  Volunteering At Schools Makes Me A Better Â鶹´«Ã½yer

  

  Speaking to elementary school students about the importance of college and other opportunities after high school — especially students who may not see those paths reflected in their daily lives — not only taught me the importance of giving back, but also helped to sharpen several skills essential to a successful legal practice, says Guillermo Escobedo at Constangy.

• 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.

• Series

  Â鶹´«Ã½ 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.