Expert Analysis

• FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny

  

  Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.

• Lead Like 'Ted Lasso' By Embracing Cognitive Diversity

  

  The Apple TV+ series “Ted Lasso” aptly illustrates how embracing cognitive diversity can be a winning strategy for teams, providing a useful lesson for law firms, which can benefit significantly from fresh, diverse perspectives and collaborative problem-solving, says Paul Manuele at PR Manuele Consulting.

• Preparing For Increased Scrutiny Of Tech Supply Chains

  

  The U.S. Department of Commerce's recent action prohibiting sales of a Russia-based technology company's products in the U.S. is the first determination under the information technology supply chain rule, and signals plans to increase enforcement of protections that target companies in designated foreign adversary jurisdictions, say attorneys at Debevoise.

• Chevron's End Puts Target On CFPB's Aggressive BNPL Rule

  

  A recent interpretative rule by the Consumer Financial Protection Bureau, subjecting buy-now, pay-later loans to the same regulations as credit cards, is unlikely to survive post-Chevron challenges of the rule's partisan and shaky logic, say Scott Pearson and Bryan Schneider at Manatt.

• Boeing Plea Deal Is A Mixed Bag, Providing Lessons For Cos.

  

  The plea deal for conspiracy to defraud regulators that Boeing has tentatively agreed to will, on the one hand, probably help the company avoid further reputational damage, but also demonstrates to companies that deferred prosecution agreements have real teeth, and that noncompliance with DPA terms can be costly, says Edmund Vickers at Red Lion Chambers.

• Keeping Up With Carbon Capture Policy In The US And EU

  

  Recent regulatory moves from the U.S. Environmental Protection Agency and the European Commission in the carbon capture, sequestration and storage space are likely to further encourage the owners and operators of fossil fuel-fired power plants to make decisions on shutdowns or reconfiguration to meet the expanding requirements, say Inosi Nyatta and Silvia Brünjes at Sullivan & Cromwell.

• New State Climate Liability Laws: What Companies Must Know

  

  New legislation in Vermont and New York creating liability and compliance obligations for businesses deemed responsible for climate change — as well as similar bills proposed in California, Massachusetts and Maryland — have far-reaching implications for companies, so it is vital to remain vigilant as these initiatives progress, say Gregory Berlin and Jeffrey Dintzer at Alston & Bird.

• EU Investor-State Dispute Transparency Rules: Key Points

  

  The European Union's recent vote to embrace greater transparency for investor-state arbitration will make managing newly public information more complex for all parties in a dispute — so it is important for stakeholders to understand the risks and opportunities involved, say Philip Hall, Tara Flores and Charles McKeon at Thorndon Partners.

• Analyzing FDA Draft Guidance On Clinical Trial Diversity

  

  In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.

• Justices' Criminal Law Decisions: The Term In Review

  

  Each of the 11 criminal decisions issued in the U.S. Supreme Court’s recently concluded term is independently important, but taken together, they reveal trends in the court’s broader approach to criminal law, presenting both pitfalls and opportunities for defendants and their counsel, says Kenneth Notter at MoloLamken.

• What's New In The AI Healthcare Regulatory Space

  

  Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.

• Biden Policy Gives Employers New Ways To Help Dreamers

  

  A new Biden administration immigration policy makes the process more predictable for Deferred Action for Childhood Arrivals recipients to seek employment visas, and, given uncertainties surrounding DACA’s future, employers should immediately determine which of their employees may be eligible, says Jennifer Kim at Moore & Van Allen.

• 25 Years Of OECD's Anti-Bribery Convention

  

  Marking its 25th anniversary this year, the Organization for Economic Cooperation and Development's anti-bribery convention has advanced legislative reforms and reshaped corporate conduct in dozens of countries amid the persistent challenges of uneven enforcement and political pressure, say attorneys at Debevoise.

• Despite Calif. Delays, Climate Disclosure Rules Are Coming

  

  Progress continues on state, federal and international climate disclosure regimes, making compliance a key concern for companies — but the timeline for implementation of California's disclosure laws remains unclear due to funding and timing disputes, says David Smith at Manatt Phelps.

• Series

  After Chevron: Bid Protest Litigation Will Hold Steady For Now

  

  Though the substantive holding of Loper Bright is unlikely to affect bid protests because questions of statutory interpretation are rare, the spirit of the U.S. Supreme Court's decision may signal a general trend away from agency deference even on the complex technical issues that often arise, say Kayleigh Scalzo and Andrew Guy at Covington.