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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

Law 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.

Navigating Potential Sources Of Tariff-Related Contract Risk

As the tariff landscape continues to shift, companies must anticipate potential friction points arising out of certain common contractual provisions, prepare to defend against breach claims, and respond to changing circumstances in contractual and treaty-based relationships, say attorneys at Debevoise.

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.

Should Patent Disputes Be Filed In The ITC Or UPC?

When companies must choose between initiating patent litigation in the U.S. International Trade Commission or the European Union's Unified Patent Court, the ITC may offer a few distinct advantages, but ultimately the decision requires consideration of case-specific factors, say attorneys at White & Case.

Opinion

NJ Should Align With Federal Rule On Expert Testimony

The time is right to amend Rule 702 of the New Jersey Rules of Evidence to align it with the recently amended Rule 702 of the Federal Rules of Evidence and clarify the standard for admissibility of expert testimony, says Timothy Freeman at Tanenbaum Keale.

2 NY Rulings May Stem Foreign Co. Derivative Suits

In recent decades, shareholders have challenged the internal affairs doctrine by bringing a series of derivative actions in New York state court on behalf of foreign corporations, but the New York Court of Appeals' recent rulings in Ezrasons v. Rudd and Haussmann v. Baumann should slow that trend, say attorneys at Cleary.

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.

Opinion

Congress Should Pass IP Reform, Starting With 3 Patent Bills

Congress is considering a trio of bipartisan bills to fix patent law problems that have cropped up over the past two decades, and it shouldn't stop there — addressing two other intellectual property issues is critical for America's economy, says retired Judge Kathleen O'Malley at the Council for Innovation Promotion.

Class Standing Issues Still Murky After Justices Punt LabCorp

While litigants and district courts had hoped the U.S. Supreme Court's ruling in LabCorp v. Davis would provide much-needed clarity on the interplay between Article III standing and class certification, the court's failure to rule on the issue leaves disagreement, confusion and uncertainty for stakeholders, says Erica Rutner at Cozen O'Connor.

When Reshoring, IP Issues Require A Strong Action Plan

With recent headlines highlighting tariffs as high as 3,521%, more firms will contemplate reshoring manufacturing to the U.S., and they will need to consider important intellectual property issues as part of this complex, expensive and lengthy undertaking, say attorneys at Norton Rose.

Series

Volunteering At Schools Makes Me A Better Lawyer

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.

Prospects And Challenges For Expert Evidence At The UPC

Expert testimony on economic or damages-related issues will likely play a larger part in Unified Patent Court proceedings in the near future, potentially presenting unique challenges for experts, counsel and judges alike, say analysts at Charles River.