“Dear Sponsor, we regret to inform you…”—not the message any drug developer wants to receive. Cell-based assays have repeatedly appeared in FDA Complete Response Letters (CRLs). So, what is going wrong, and how can development teams better prepare? In this webinar, we’ll examine recent FDA CRLs to identify the most common deficiencies related to cell-based assays in regulatory submissions. Drawing directly from FDA observations and current guidance documents, we’ll translate these findings into practical recommendations that can help developers build more robust assays, strengthen validation strategies, and reduce regulatory risk. Whether you’re developing biologics, cell therapies, or gene therapies, this session will provide insight into what the FDA expects and how to avoid the pitfalls that continue to delay regulatory approvals.

What You’ll Learn

• The most common cell-based assay deficiencies identified in recent FDA CRLs.
• The regulatory expectations behind these FDA observations.
• Practical strategies to strengthen cell-based assay development, validation, and regulatory readiness.