Expert Analysis

• FDA Biosimilar Guidance Should Ease Biologics Development

  

  New draft guidance from the U.S. Food and Drug Administration, indicating that the agency may no longer routinely require comparative efficacy studies when other evidence provides sufficient assurance of biosimilarity, underscores the FDA's trust in analytical technology as a driver of biologics access, say attorneys at Hogan Lovells.

• Preparing For Treasury's Small Biz Certification Audits

  

  To prepare for the U.S. Department of the Treasury’s recently announced audit of small and disadvantaged government contractors, companies should assess the records that supported their prior certifications and confirm their current eligibility, particularly if they share ownership with another entity or were recently acquired, say attorneys at Morgan Lewis.

• Navigating Sanctions Against Colombia's Head Of State

  

  To limit their exposure from recent sanctions that prohibit dealings with Colombia’s president and specific officials, it is critical that U.S. companies gain a fulsome understanding of potential touchpoints, establish controls to avoid engagement and, if necessary, seek U.S. government approval, say attorneys at Perkins Coie.

• Litigation Funding Could Create Ethics Issues For Attorneys

  

  A litigation investor’s recent complaint claiming a New York mass torts lawyer effectively ran a Ponzi scheme illustrates how litigation funding arrangements can subject attorneys to legal ethics dilemmas and potential liability, so engagement letters must have very clear terms, says Matthew Feinberg at Goldberg Segalla.

• Ill. State Farm Suit Tests State Insurance Data Demand Limits

  

  The Illinois Department of Insurance's recently filed suit against State Farm, seeking nationwide data on its homeowners insurance, raises important issues as to the breadth, and possible overreach, of a state's regulatory authority, says Stephanie Pierce at Kutak Rock.

• How New FinCEN FAQs Simplify Suspicious Activity Reporting

  

  New guidance from the Financial Crimes Enforcement Network and federal banking agencies that gives financial institutions more flexibility in meeting suspicious activity reporting obligations indicates the administration is following through on its promise to streamline the U.S. anti-money laundering regime, say attorneys at Davis Polk.

• What Shutdown's End Means For Worker Safety Enforcement

  

  The Occupational Safety and Health Administration and Mine Safety and Health Administration may emerge from the government shutdown struggling to juggle complaint backlogs, litigation delays and newly enacted policies with a reduced and demoralized workforce, so employers should stay alert, say attorneys at Conn Maciel.

• SEC's Dual Share Class Approval Signals New Era For ETFs

  

  The U.S. Securities and Exchange Commission's recent approval of the dual share class structure marks a landmark moment for the U.S. fund industry, opening the door for asset managers to benefit from combining mutual fund and exchange-traded fund share classes under a single portfolio, say Ilan Guedj at Bates White and Brian Henderson at George Washington University.

• Calif. Species Protections Will Increase Compliance Burdens

  

  California's recently enacted A.B. 1319 automatically protects species when the federal government rolls back its own protections — which could mean an onslaught of state-level compliance mandates for the regulated community that come with no advance notice or public hearings, says attorney David Smith.

• UK Tribunal's Clearview Decision Expands GDPR Application

  

  The Upper Tribunal’s recent decision in Information Commissioner v. Clearview AI is an important ruling on the extraterritorial reach of the European Union and U.K. General Data Protection Regulations, broadening behavioral monitoring to include not only activity by the company, but also its client, says Edward Machin at Ropes & Gray.

• E-Discovery Quarterly: Recent Rulings On Dynamic Databases

  

  Several recent federal court decisions illustrate how parties continue to grapple with the discovery of data in dynamic databases, so counsel involved in these disputes must consider how structured data should be produced consistent with the requirements of the Federal Rules of Civil Procedure, say attorneys at Sidley.

• Assessing The SEC's Changing Approach To NFT Regulation

  

  Early U.S. Securities and Exchange Commission actions on nonfungible tokens pushed for broad regulation, but subsequent court decisions — including a recent California federal court ruling in Adonis Real v. Yuga Labs — and SEC commissioners' statements have narrowed the regulatory focus toward a more fact-specific approach, say attorneys at Wilson Elser.

• Where Crypto Mixing Enforcement Is Headed From Here

  

  Recent developments involving crypto mixers, particularly the Tornado Cash verdict, demonstrate that the Justice Department's shift away from regulation by prosecution does not mean total immunity, rather reflecting an approach that prioritizes both innovation and accountability, says David Tarras at Tarras Defense.

• Stadium Security Takeaways Amid Gaps In Drone Regulation

  

  As the risk of drones to sports stadium security grows, legal practitioners in the industry should focus on the need for rapid deployment of emergency services, crowd control, communications, strong organizational structure, and engagement across local, state and federal authorities, says Jennifer Daskal at Venable.

• The Legal Issues With AI Agents In Consumer Transactions

  

  Enabling artificial intelligence agents to handle not just research and recommendations, but the execution of purchases themselves, fundamentally alters commercial relationships and introduces new practical and legal questions for card issuers, merchants, acquirers and consumers, say attorneys at Davis Wright.