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  New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting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.

• Rebuttal

  Time For Congress To Let Qualified Older Pilots Keep Flying

  

  While a previous Law360 guest article affirmed the current law requiring airline pilots to retire at age 65, the facts suggest that the pilots, their unions, the airlines and the flying public will all benefit if Congress allows experienced, medically qualified aviators to stay in the cockpit, say Allen Baker and Bo Ellis at Let Experienced Pilots Fly.

• Does Expert Testimony Aid Preliminary IPR Responses?

  

  Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.

• Fostering Employee Retention Amid Shaky DEI Landscape

  

  Ongoing challenges to the legality of corporate diversity, equity and inclusion programs are complicating efforts to use DEI as an employee retention tool, but with the right strategic approach employers can continue to recruit and retain diverse talent — even after the FTC’s ban on noncompetes, says Ally Coll at the Purple Method.

• 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.

• 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.

• 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.

• Best Practices For Space Security In Our Connected World

  

  NASA's recently published space security guide is another indication that cyber-resilience has become a global theme for the space and satellite sector, as well as a useful reference for companies and organizations reviewing their cybersecurity frameworks or looking to partner with the U.S. agency, says Hayley Blyth at Bird & Bird.

• Opinion

  SEC Doesn't Have Legal Authority For Climate Disclosure Rule

  

  Instead of making the required legal argument to establish its authority, the U.S. Securities and Exchange Commission's climate-related disclosure rule hides behind more than 1,000 references to materiality to give the appearance that its rule is legally defensible, says Bernard Sharfman at RealClearFoundation.

• What 100 Federal Cases Suggest About Changes To Chevron

  

  With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.