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Expert Analysis

• FDA Transparency Plans Raise Investor Disclosure Red Flags

  

  The U.S. Food and Drug Administration鈥檚 recently announced intent to publish complete response letters for unapproved drugs and devices implicates certain investor disclosure requirements under securities laws, making it necessary for life sciences and biotech companies to adopt robust controls going forward, say attorneys at Arnold & Porter.

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  Being A Professional Wrestler Makes Me A Better Lawyer

  

  Pursuing my childhood dream of being a professional wrestler has taught me important legal career lessons about communication, adaptability, oral advocacy and professionalism, says Christopher Freiberg at Midwest Disability.

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  Law School's Missed Lessons: Adapting To The Age Of AI

  

  Though law school may not have specifically taught us how to use generative artificial intelligence to help with our daily legal tasks, it did provide us the mental building blocks necessary for adapting to this new technology 鈥� and the judgment to discern what shouldn鈥檛 be automated, says Pamela Dorian at Cozen O'Connor.

• Ch. 11 Ruling Voiding $2M Litigation Funding Sends A Warning

  

  A recent Texas bankruptcy court decision that a postconfirmation litigation trust has no obligations to repay a completely drawn down $2 million litigation funding agreement serves as a warning for estate administrators and funders to properly disclose the intended financing, say attorneys at Kleinberg Kaplan.

• DOJ's Novel Cybersecurity FCA Case Is A Warning To Medtech

  

  The U.S. Department of Justice's recent False Claims Act settlement with Illumina over alleged cybersecurity deficiencies suggests that enforcement agencies and whistleblowers are focusing attention toward cybersecurity in life sciences and medical tech, but also reveals key unanswered questions about the legal viability of such allegations, say attorneys at Morgan Lewis.

• Demystifying The Civil Procedure Rules Amendment Process

  

  Every year, an advisory committee receives dozens of proposals to amend the Federal Rules of Civil Procedure, most of which are never adopted 鈥� but a few pointers can help maximize the likelihood that an amendment will be adopted, says Josh Gardner at DLA Piper.

• With Obligor Ruling, Ohio Justices Calm Lending Waters

  

  A recent decision by the Ohio Supreme Court, affirming a fundamental principle that lenders have no duty to disclose material risks to obligors, provides clarity for commercial lending practices in Ohio and beyond, and offers a reminder of the risks presented by guarantee arrangements, says Carrie Brosius at Vorys.

• How 2nd Circ. Cannabis Ruling Upends NY Licensing

  

  A recent Second Circuit decision in Variscite NY Four v. New York, holding that New York's extra-priority cannabis licensing preference for applicants with in-state marijuana convictions violates the dormant commerce clause, underscores that state-legal cannabis markets remain subject to the same constitutional constraints as other economic markets, say attorneys at Harris Beach.

• Parenting Skills That Can Help Lawyers Thrive Professionally

  

  As kids head back to school, the time is ripe for lawyers who are parents to consider how they can incorporate their parenting skills to build a deep, meaningful and sustainable legal practice, say attorneys at Alston & Bird.

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  Teaching Trial Advocacy Makes Us Better Lawyers

  

  Teaching trial advocacy skills to other lawyers makes us better litigators because it makes us question our default methods, connect to young attorneys with new perspectives and focus on the needs of the real people at the heart of every trial, say Reuben Guttman, Veronica Finkelstein and Joleen Youngers.

• Federal AI Action Plan Marks A Shift For Health And Bio Fields

  

  The Trump administration's recent artificial intelligence action plan significantly expands federal commitments across biomedical agencies, defining a pivotal moment for attorneys and others involved in research collaborations, managing regulatory compliance and AI-related intellectual property, says Mehrin Masud-Elias at Arnold & Porter.

• Preparing For DEA Rescheduling Of 2 Research Chemicals

  

  A recent decision to allow the U.S. Drug Enforcement Administration to reclassify two research psychedelics in Schedule I under the Controlled Substances Act may pose significant barriers to scientific study, including stringent registration requirements, heightened security protocols and burdensome reporting obligations, say Kimberly Chew at Husch Blackwell and Jackie von Salm at Psilera.

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  Adapting To Private Practice: From Texas AUSA To BigLaw

  

  As I learned when I transitioned from an assistant U.S. attorney to a BigLaw partner, the move from government to private practice is not without its hurdles, but it offers immense potential for growth and the opportunity to use highly transferable skills developed in public service, says Jeffery Vaden at Bracewell.

• Advice For 1st-Gen Lawyers Entering The Legal Profession

  

  Nikki Hurtado at The Ferraro Law Firm tells her story of being a first-generation lawyer and how others who begin their professional journeys without the benefit of playbooks handed down by relatives can turn this disadvantage into their greatest strength.

• High Court E-Cig Ruling Opens Door For FDA Challenges

  

  There will likely be more challenges to marketing denial orders brought before the Fifth Circuit following the Supreme Court's recent ruling in U.S. Food and Drug Administration v. R.J. Reynolds Vapor Co., where litigants have generally had greater success, say attorneys at Troutman Pepper.