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.

Opinion

SNAP Rule Confusion Risks A Compliance Crisis

Recent Supplemental Nutrition Assistance Program food restriction waivers pose a compliance crisis for legal practitioners advising food retailers, amid higher costs and lack of a coherent national standard, says Tyson-Lord Gray at Yeshiva University’s Benjamin N. Cardozo School of Law.

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 The 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.

An Instructive Reminder On Appealing ITC Determinations

A recent Federal Circuit decision, partially dismissing Crocs' appeal of a U.S. International Trade Commission verdict as untimely, offers a powerful reminder that the ITC is a creature of statute and that practitioners would do well to interpret those statutes conservatively, says Derrick Carman at Robins Kaplan.

Ruling Puts Guardrails On FTC Merger Filing Rule Expansion

A Texas federal court recently vacated the Federal Trade Commission's overhaul of the Hart-Scott-Rodino premerger notification form, in a significant setback for the antitrust agencies, say attorneys at Reed Smith.

Opinion

Bridging The Bench And Bars To Uphold The Rule Of Law

In a moment when the judiciary faces unprecedented partisan attacks and public trust in our courts is fragile, and with the stakes being especially high for mass tort cases, attorneys on both sides of the bench have a responsibility to restore confidence in our justice system, say Bryan Aylstock at Aylstock Witkin and Kiley Grombacher at Bradley/Grombacher.

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.

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.