Expert Analysis

• 5 Takeaways From FDA's Biosimilars Promotion Guidance

  

  New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.

• The Legal Issues Raised In Minn. Rate Exportation Opt-Out Bill

  

  A recent Minnesota House bill would amend state law by opting out of the federal interest rate preemption and introduce several legal gray areas if passed, including issues regarding loan location, rates on credit card loans and values of state charters, says Karen Grandstrand at Fredrikson & Byron.

• Are Concessions In FDA's Lab-Developed Tests Rule Enough?

  

  Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.

• 5 Climate Change Regulatory Issues Insurers Should Follow

  

  The climate change landscape for insurers has changed dramatically recently — and not just because of the controversy over the U.S. Securities and Exchange Commission's climate-related risk disclosure rules, says Thomas Dawson at McDermott.

• How New Rule Would Change CFIUS Enforcement Powers

  

  Before the May 15 comment deadline, companies may want to weigh in on proposed regulatory changes to enforcement and mitigation tools at the disposal of the Committee on Foreign Investment in the United States, including broadened subpoena powers, difficult new mitigation timelines and higher maximum penalties, say attorneys at Venable.

• What's Extraordinary About Challenges To SEC Climate Rule

  

  A set of ideologically diverse legal challenges to the U.S. Securities and Exchange Commission's climate disclosure rule have been consolidated in the Eighth Circuit via a seldom-used lottery system, and the unpredictability of this process may drive agencies toward a more cautious future approach to rulemaking, say attorneys at Thompson Coburn.

• 8 Questions To Ask Before Final CISA Breach Reporting Rule

  

  The Cybersecurity and Infrastructure Security Agency’s recently proposed cyber incident reporting requirements for critical infrastructure entities represent the overall approach CISA will take in its final rule, so companies should be asking key compliance questions now and preparing for a more complicated reporting regime, say Arianna Evers and Shannon Mercer at WilmerHale.

• Is The Digital Accessibility Storm Almost Over?

  

  Though private businesses have faced a decadelong deluge of digital accessibility complaints in the absence of clear regulations or uniformity among the courts, attorneys at Epstein Becker address how recent federal courts’ pushback against serial Americans with Disabilities Act plaintiffs and the U.S. Department of Justice’s proposed government accessibility standards may presage a break in the downpour.

• PE In The Crosshairs Of Public And Private Antitrust Enforcers

  

  A series of decisions from a California federal court in the recently settled Packaged Seafood Products Antitrust Litigation, as well as heightened scrutiny from federal agencies, serve as a reminder that private equity firms may be exposed to liability for alleged anti-competitive conduct by their portfolio companies, say attorneys at Axinn.

• Series

  Swimming Makes Me A Better Lawyer

  

  Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.

• Mid-2024 FCA Enforcement And Litigation Trends To Watch

  

  Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.

• Key Priorities In FDIC Report On Resolving Big Bank Failures

  

  The Federal Deposit Insurance Corp.'s report last month on the resolvability of large financial institutions contains little new information, but it does reiterate key policy priorities, including the agency's desire to enhance loss-absorbing capacity through long-term debt requirements and preference for single-point-of-entry resolution strategies, say attorneys at Freshfields.

• Justices' Title VII Ruling Requires Greater Employer Vigilance

  

  The U.S. Supreme Court’s recent Muldrow v. St. Louis ruling expands the types of employment decisions that can be challenged under Title VII, so employers will need to carefully review decisions that affect a term, condition or privilege of employment, say attorneys at Morgan Lewis.

• Opinion

  SEC Should Be Allowed To Equip Investors With Climate Info

  

  The U.S. Securities and Exchange Commission's new rule to require more climate-related disclosures will provide investors with much-needed clarity, despite opponents' attempts to challenge the rule with misused legal arguments, say Sarah Goetz at Democracy Forward and Cynthia Hanawalt at Columbia University’s Sabin Center for Climate Change.

• 8 Fla. Statutes That Construction Cos. Should Prepare For

  

  In this article, Jason Lambert at Hill Ward discusses a number of recent bills out of the Florida Legislature targeting construction companies in the Sunshine State that have been sent to the governor for signature, at least some of which will have broad impacts that affected companies should prepare for ahead of the July 1 effective date.