Expert Analysis

• A Potential Shift In FDA's Approach To Drug Trial Design

  

  Recent guidance released by the U.S. Food and Drug Administration clarifying how Bayesian approaches — which combine prior knowledge with new data — may be used in clinical trials reflects the agency's continued interest in innovative trial designs that may accelerate drug approvals, say attorneys at Alston & Bird.

• US-Ukraine Reconstruction Fund Tax Exemptions Uncertain

  

  Tax provisions in the bilateral agreement to establish the U.S.-Ukraine Reconstruction Investment Fund, which recently announced it is accepting applications, are so broad and imprecise as to leave uncertainty regarding whether and when tax exemptions will apply to investors' income, say attorneys at Avellum and Debevoise.

• Locations, Permits And Power Are Key In EV Charger Projects

  

  To ensure the success of public electric vehicle charging infrastructure projects, developers, funders, site hosts and charge point operators must consider a range of factors, including location selection, distribution grid requirements and costs, and permitting and timeline impacts, says Levi McAllister at Morgan Lewis.

• Should Prediction Markets Allow Trading On Nonpublic Info?

  

  Recent trading activity, such as the Polymarket wager on the U.S. capture of Venezuelan President Nicolás Maduro, has raised questions about whether some participants may be engaging in trading that is based on material nonpublic information, and highlights ongoing uncertainty about how existing derivatives and anti-fraud rules apply to event-based contracts, say economic consultants at the Brattle Group.

• NLRB May Not See Employer-Friendly Changes Anytime Soon

  

  Despite the long-awaited confirmation of a new National Labor Relations Board general counsel and two new board members, slower case processing, the NLRB's changing priorities and an unofficial rule about a three-member majority may prevent NLRB precedent from swinging in businesses' favor this year, says Jesse Dill at Ogletree.

• FCC Satellite Co. Action Starts New Chapter For Team Telecom

  

  The Federal Communications Commission's recent settlement with satellite company Marlink marks a modest but meaningful step forward in how the U.S. regulates foreign involvement in its telecommunications sector, proving "Team Telecom" conditions are not limited to companies with substantial foreign ownership, says attorney Sohan Dasgupta.

• Series

  Trivia Competition Makes Me A Better Lawyer

  

  Playing trivia taught me to quickly absorb information and recognize when I've learned what I'm expected to know, training me in the crucial skills needed to be a good attorney, and reminding me to be gracious in defeat, says Jonah Knobler at Patterson Belknap.

• What FDA Guidance Means For Future Of Health Software

  

  Two significant final guidance documents released by the U.S. Food and Drug Administration last month reflect a targeted effort to ease innovation friction around specific areas, including singular clinical decision support recommendations and sensor-based wearables, while maintaining established regulatory boundaries, say attorneys at Covington.

• Tips For Banks Navigating AI Benefits, Risks And Regulation

  

  To understand how artificial intelligence affects banks and is used in the products and services they offer, they must examine use cases, efficiencies, benefits, risks, vendor management and oversight, as well as consider how regulators can use AI and are monitoring its use in banking activity, says Doug Hiatt at Fredrikson & Byron.

• State And Int'l Standards May Supplant EPA's GHG Rule

  

  The U.S. Environmental Protection agency's recent repeal of its 2009 finding that greenhouse gases endanger public health will likely increase regulatory uncertainty, as states attempt to fill the breach with their own regulatory regimes and some companies shift focus to international climate benchmarks instead, say attorneys at ArentFox Schiff.

• Opinion

  Federal Preemption In AI And Robotics Is Essential

  

  Federal preemption offers a unified front at a decisive moment that is essential for safeguarding America's economic edge in artificial intelligence and robotics against global rivals, harnessing trillions of dollars in potential, securing high-skilled jobs through human augmentation, and defending technological sovereignty, says Steven Weisburd at Shook Hardy.

• Coinbase Ruling Outlines Litigation Committee Conflict Risks

  

  The Delaware Court of Chancery's recent rejection in Grabski v. Andreessen of a special litigation committee's motion to terminate or settle — its first such decision in over a decade — over conflict concerns highlights why the independence of SLC counsel matters just as much as that of committee members, says Joel Fleming at Equity Litigation Group.

• Series

  Law School's Missed Lessons: What Cross-Selling Truly Takes

  

  Early-career attorneys may struggle to introduce clients to practitioners in other specialties, but cross-selling becomes easier once they know why it’s vital to their first years of practice, which mistakes to avoid and how to anticipate clients' needs, say attorneys at Moses & Singer.

• OCC Mortgage Escrow Rules Add Fuel To Preemption Debate

  

  Two rules proposed in December by the Office of the Comptroller of the Currency, which would preempt state laws requiring national banks to pay interest on mortgage escrow accounts, are a bold new federal gambit in the debate over how much authority Congress intended to hand state regulators under the Dodd-Frank Act, says Christian Hancock at Bradley Arant.

• CFIUS Initiative May Smooth Way For Some Foreign Investors

  

  A new program that will allow certain foreign investors to be prevetted and admitted to fast-track approval by the Committee on Foreign Investment in the United States will likely have tangible benefits for investors participating in competitive M&A, say attorneys at Simpson Thacher.