REGULATORY ARTICLES

• 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.

• FDA Issues New Draft Guidances On Cancer Clinical Trial Eligibility Criteria

  Understand the latest FDA guidance on cancer clinical trials with summary and content from Marjorie Zettler, Ph.D., MPH.

• Understanding And Navigating Diverse Regulatory Environments

  Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.