FDA Framework For Personalized Therapies Raises Questions

The U.S. Food and Drug Administration's new plausible mechanism framework for developing individualized therapies reflects the agency's focus on rare-disease drugs, but numerous significant, unresolved issues cast uncertainty on how effective the framework will be in practice, say attorneys at Ropes & Gray.

What's Next For The Advanced Air Mobility Sector

The U.S. Department of Transportation’s recent selection of electric vertical takeoff and landing pilot program participants marks a transition from aspirational policy to accountable implementation, and regulatory strategy should be at the center of business planning across the advanced air mobility ecosystem, say attorneys at Morgan Lewis.

Emissions Permits May Not Override Pollution Exclusions

Two recent coverage rulings from the Illinois Supreme Court and the Third Circuit suggest a trend among appellate courts to deny coverage under pollution exclusions, even when the emissions happened pursuant to a government permit, say attorneys at Simpson Thacher.

5 Tips For Navigating Your Firm's All-Attorney Summit

Excerpt from Practical Guidance

Law firm retreats should be approached strategically as they present valuable opportunities to advance both the firm's objectives and attorneys' professional development through meaningful participation, building and strengthening internal relationships, and proactive follow-up, says James Argionis at Cozen O’Connor.

CFTC's No-Action Relief Fuels Energy Market Competition

The U.S. Commodity Futures Trading Commission recently launched a pilot program aimed at expanding access to energy markets, reflecting a shift toward supporting robust derivatives markets that balance regulatory safeguards with the needs of commodity end users, say attorneys at Moore & Van Allen.

New NLRB GC Likely To Prioritize Efficiency Over Policy Shifts

After the National Labor Relations Board operated without a quorum for nearly a year, general counsel Crystal Carey's early memoranda reflect a shift away from sweeping policy changes and toward clearing the case backlog, creating an environment that rewards employers' preparation and efficiency over prolonged litigation, says Michael Passarella at Olshan Frome.

Opinion

Clarity Act Would Clear Welcome Pathways For Blockchain

The framework proposed under the Senate Banking Committee's version of the Clarity Act creates reasonable compliance obligations and meaningful token-distribution opportunities that would open the door for more U.S.-based blockchain projects, without the heightened risk of securities litigation and regulatory enforcement, says Karen Ubell at Goodwin.

How Bankrupt Cos. Can Seek Refunds For Illegal Tariffs

In light of the U.S. Supreme Court's recent decision striking down President Donald Trump's International Emergency Economic Powers Act tariffs as illegal, some companies may have strong prospects for recovering refunds from the government, and trustees in bankruptcy may have a significant role to play in seeking such recovery, say attorneys at Stinson.

NYC Leave Law Expands Compliance Beyond Written Policies

Following recent amendments to New York City's Earned Safe and Sick Time Act that expand its uses, give employees 32 hours of immediately available time off and create a right to request schedule changes, compliance now turns on whether employees can use time off without facing barriers or discipline, say attorneys at Polsinelli.

Scrutiny Of Nursing Home Practices Marks Inflection Point

Recent congressional inquiries into UnitedHealth Group's Medicare Advantage-linked nursing home practices raise questions about whether financial metrics are allowed to influence decisions governed by the standard of care, and could implicate duties imposed by federal regulations, state negligence laws and elder abuse statutes, says Lindsey Gale at Rafferty Domnick.

Legal And Industry Impacts Of America's Maritime Action Plan

America's Maritime Action Plan, unveiled by the White House last month, introduces changes to trade investigations, a new maritime trust fund and more — adding regulatory and compliance obligations for companies and counsel, but also new avenues for client engagement in project finance, contract negotiation and dispute resolution, say attorneys at Holland & Knight.

5 Gov't Contractor Tips Following Anthropic Risk Designation

The Pentagon's designation of Anthropic as a supply chain risk is an unprecedented action that raises significant legal questions, and with government contractors already receiving directives and inquiries concerning their use of Anthropic products and services, there are several strategies contractors can use to manage risk, say attorneys at Mayer Brown.

6 Noteworthy Changes From SEC Enforcement Manual Update

Recent updates to the U.S. Securities and Exchange Commission’s enforcement manual represent a commitment to transparency and fair process, with the signature change being a requirement that staff make certain probative evidence available during the Wells process, say attorneys at Debevoise.

Series

Coaching Soccer Makes Me A Better Lawyer

Coaching youth soccer for my 7-year-old son's team has sharpened how I communicate with clients, prepare witnesses, work within teams and think about leadership, making me a more thoughtful and effective lawyer in many ways, says Joshua Holt at Smith Currie.

How Internal Reporting Could Benefit Antitrust Whistleblowing

As the Justice Department's new antitrust whistleblower program stands to raise questions over the interaction between rewards and corporate leniency, incentivizing internal reporting first could increase the likelihood that the Antitrust Division receives the high-quality evidence needed to successfully prosecute cartel cases, says Daniel Oakes at Axinn.