Expert Analysis

• FDA's Off-Label Comms Guidance Is A Reluctant Step Forward

  

  The U.S. Food and Drug Administration's latest draft guidance expands its safe harbor for health care providers that communicate information about their products' off-label uses, but does not fully resolve the First Amendment disconnect between federal courts and the agency's regulatory goals, say Jeffrey Shapiro and Lisa Dwyer at King & Spalding.

• How Biden's AI Order Stacks Up Against Calif. And G7 Activity

  

  Evaluating the federal AI executive order alongside the California AI executive order and the G7's Hiroshima AI Code of Conduct can offer a more robust picture of key risks and concerns companies should proactively work to mitigate as they build or integrate artificial intelligence tools into their products and services, say attorneys at Jenner & Block.

• Reading Between The Lines Of HHS' National Lab Opinion

  

  The U.S. Department of Health and Human Services' Office of Inspector General recently rejected a national laboratory's request to pay a referring lab to process specimens, but the request might have been an attempt to exploit the OIG's advisory opinion process for a competitive advantage, says Mary Kohler at Kohler Health Law.

• ITC Ban On Apple Watch Could Still Be Reversed

  

  The U.S. International Trade Commission's recent final decision that the Apple Watch infringed two patents owned by Masimo Corp. was a rare instance of a popular consumer product being hit with an absolute importation ban, but it's possible that President Joe Biden could assert his power to reverse the ITC decision, says Benjamin Horton at Marshall Gerstein.

• A Closer Look At Proposed HHS Research Misconduct Rule

  

  The U.S. Department of Health and Human Services' proposed updates to its policies on research misconduct codify many well-known best practices, but also contain some potential surprises for the research community and counsel, say attorneys at Hogan Lovells.

• Incontinence Drug Ruling Offers Key Patent Drafting Lessons

  

  In a long-awaited decision in Astellas v. Teva and Sandoz, an English court found that the patent for a drug used to treat overactive bladder syndrome had not been infringed, highlighting the interaction between patent drafting and litigation strategy, and why claim infringement is as important a consideration as validity, says George McCubbin at Herbert Smith.

• Why Hemp-Synthesized Intoxicants Need Uniform Regs

  

  State laws regulating hemp-synthesized intoxicants are a patchwork with little consistency between any given state, and without the adoption of a uniform regulatory framework, producers and consumers alike will need to be very cautious, say Dylan Anderson and Seth Goldberg at Duane Morris.

• Opinion

  Life Sciences Regulators Must Write Cloud-Specific Guidance

  

  As cloud services continue to revolutionize the life sciences industry's ability to conduct regulated activities, the U.S. Food and Drug Administration and other regulators should update their data management policies to clearly support and encourage use of cloud technology, say Nate Brown and Marlee Gallant at Akin.

• Fed. Circ. Elekta Holding May Make Patent Prosecution Harder

  

  The Federal Circuit's recent analysis of obviousness in its Elekta v. Zap Surgical Systems decision will make prosecuting patents harder, as parties will now need to consider whether to argue that cited patents are nonanalogous, say Sean Murray and Jeremiah Helm of Knobbe Martens.

• Attorneys, Law Schools Must Adapt To New Era Of Evidence

  

  Technological advancements mean more direct evidence is being created than ever before, and attorneys as well as law schools must modify their methods to account for new challenges in how this evidence is collected and used to try cases, says Reuben Guttman at Guttman Buschner.

• Series

  ESG Around The World: The UK

  

  Following Brexit, the U.K. has adopted a different approach to regulating environmental, social and governance factors from the European Union — an approach that focuses on climate disclosures by U.K.-regulated entities, while steering clear of the more ambitious objectives pursued by the EU, say attorneys at Dechert.

• Boeing Opinion Strikes Blow Against Overpayment Theory

  

  The Fifth Circuit's decision in Earl v. Boeing Co. casts doubt on consumers' standing to bring claims of overpayment for products later revealed to have defects — and suggests that it's more likely that those products would have been removed from the market, driving up the price of alternatives, say attorneys at Bush Seyferth.

• Tips For Litigating Against Pro Se Parties In Complex Disputes

  

  Litigating against self-represented parties in complex cases can pose unique challenges for attorneys, but for the most part, it requires the same skills that are useful in other cases — from documenting everything to understanding one’s ethical duties, says Bryan Ketroser at Alto Litigation.

• What Pharma Cos. Must Know About FDA Off-Label Guidance

  

  The U.S. Food and Drug Administration recently issued draft guidance on how pharmaceutical companies should share research on off-label use of medical devices, outlining how firms could avoid enforcement action — especially when disseminating self-created content about their own products, say Jacqueline Berman and Maarika Kimbrell at Morgan Lewis.

• It's Time To Prescribe Frameworks For AI-Driven Health Care

  

  As health care providers begin to adopt artificial intelligence in clinical settings, new legal and regulatory challenges are emerging, with the critical issue being balancing AI's benefits and innovations in health care while ensuring patient safety and provider accountability, say attorneys at Kirkland.