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

The FDA's new draft guidance on cell and gene therapy (CGT) development provides a crucial roadmap for navigating the complexities of this rapidly evolving field. This article summarizes key takeaways from the 40-page document, including the importance of early engagement with the FDA, ensuring product quality and safety through rigorous screening and testing, and establishing a robust Chemistry, Manufacturing, and Controls (CMC) strategy.

The guidance also emphasizes the role of preclinical studies in evaluating safety and efficacy, highlighting the need for long-term monitoring and collaborative approaches to address the unique challenges of CGT development. Access the full article to learn more about how to successfully navigate the CGT landscape and bring innovative treatments to patients.