REGULATORY ARTICLES

• Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers

  The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

• How HHS Budget Cuts And Vaccine Hesitancy Threaten Clinical Trial Operations — And What Leaders Can Do

  Prof. Stacey B. Lee, Ph.D., examines how the recent Department of Health and Human Services (HHS) staffing cuts and vaccine hesitancy combine to make clinical research much more challenging.

• Biopharma R&D Faces Productivity And Attrition Challenges In 2025

  Evaluate VP of Thought Leadership Daniel Chancellor discusses trends for 2025 as the surge in R&D, coupled with rapidly evolving industry dynamics, presents a productivity and attrition challenge for the industry.

• Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ

  The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations, and more.

• Unraveling The Complexity Of Cell Therapy: Advancements And Challenges

  Cell therapy has emerged as a powerful tool for addressing critical medical challenges, but its rapid evolution necessitates a clear regulatory framework and consistent terminology.

• Navigating The Cell And Gene Regulatory Landscape

  Navigating the complex regulatory landscape is essential for cell and gene therapy success. Explore key considerations, challenges, and best practices for companies operating in this space.

• AI Is A Tool — Not A Replacement — For Human Innovation In Drug Discovery

  This attorney provides practical advice. Can artificial intelligence (AI) make drug discovery easier? Yes! Will we lose the human component essential to the innovation culture? No.

• When Consumer Protection, Unfair Trade Practices, And AI Collide

  The EU, and a growing number of U.S. state governments, are extending consumer protection laws to AI technologies. Life sciences companies should monitor new policy developments and understand how and where specific uses of AI will be regulated.

• USPTO Proposed 'Terminal Disclaimer' Rule Could Impact Life Science Patent Protections

  A proposed rule change by the USPTO to tie patent validity together based on the filing of terminal disclaimers would have a significant impact on how life sciences patents are prosecuted. 

• Trendspotting: COVID-19 Related Investor Lawsuit Court Decisions

  Court rulings on COVID-19 related investor lawsuits over the last three years have been mixed, but manufacturing issues related to vaccine production have proven to be the strongest claims against product developers.