Expert Analysis

• FDA Transparency Plans Raise Investor Disclosure Red Flags

  

  The U.S. Food and Drug Administration’s 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.

• Rising USCIS Denials May Signal Reverse On Signature Policy

  

  Increasingly, U.S. Citizenship and Immigration Services appears to be issuing denials and requests for evidence in cases where petitioners digitally affix handwritten signatures to paper-based petitions, upending a long-standing practice with potentially grave consequences for applicants, says Sherry Neal at Corporate Immigration.

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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.

• How FDIC Appeals Plan Squares With Fed, OCC Processes

  

  The Federal Deposit Insurance Corp.'s recent proposal to revise its appeals process merits a fresh comparison to the appeals systems of the Federal Reserve and Office of the Comptroller of the Currency, and would provide institutions with greater transparency and independence, say attorneys at Alston & Bird.

• How GILTI Reform Affects M&A Golden Parachute Planning

  

  Deal teams should evaluate the effect of a recent seemingly technical change to U.S. international tax law on the golden parachute analysis that often plays a critical part of many corporate transactions to avoid underestimating its impact on an acquirer's worldwide taxable income following a triggering transaction, say attorneys at MoFo.

• SEC Rulemaking Radar: The Debut Of Atkins' 'New Day'

  

  The U.S. Securities and Exchange Commission's regulatory flex agenda, published last week, demonstrates a clear return to appropriately tailored and mission-focused rulemaking, with potential new rules applicable to brokers, exchanges and trading, among others, say attorneys at Goodwin.

• DOJ's New Initiative Puts Title IX Compliance In Spotlight

  

  Following the federal government's recent guidance regarding enhanced enforcement of discrimination on the basis of sex, organizations should evaluate whether they fall under the aegis of Title IX's scope, which is broader than many realize, and assess discrimination prevention opportunities, say attorneys at Foley & Lardner.

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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 — and the judgment to discern what shouldn’t 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.

• Why Fla. Ruling Is A Call To Action For Foreclosure Counsel

  

  A Florida state court's recent decision in Open Range Properties v. AmeriHome Mortgage has sent ripples through the banking industry and the legal community, and signals a new era of heightened scrutiny and procedural rigor in foreclosure litigation, says Andrew McBride and Adams & Reese.

• Insuring Against FCA Risk In Shifting Trade Landscape

  

  In today's heightened trade enforcement environment, companies should proactively assess whether their insurance programs are positioned to respond to potential False Claims Act or customs-related claims, including reviewing directors and officers, professional liability, and representations and warranties policies for key terms, say attorneys at Pillsbury.

• What To Expect As Trump's 401(k) Order Materializes

  

  Following the Trump administration’s recent executive order on 401(k) plan investments in alternative assets like cryptocurrencies and real estate, the U.S. Department of Labor and the U.S. Securities and Exchange Commission will need to answer several outstanding questions before any regulatory changes are implemented, say attorneys at Cleary.

• 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 — but a few pointers can help maximize the likelihood that an amendment will be adopted, says Josh Gardner at DLA Piper.

• How The 5th, DC Circuits Agreed On FCC Forfeiture Orders

  

  The Fifth and D.C. Circuits split this year on the Federal Communications Commission's process for adjudicating enforcement actions, but both implicitly recognized the problem with penalizing a party based on a forfeiture order that has not yet been challenged in any way in court, says Jared Marx at HWG.