With the FDA’s new transparency initiative, the industry now has direct access to a wave of Complete Response Letters (CRLs)—many of which center around preventable issues in CMC and regulatory alignment. This session will examine key lessons from recent CGT-related CRLs and demonstrate how sponsors can avoid similar pitfalls through proactive regulatory planning, integrated submission strategy, and the application of a Virtual Development Center (VDC) model. The session will highlight real-world examples and offer actionable insights for regulatory leaders preparing INDs, BLAs, and high-risk programs.
Learning Objectives:
Understand emerging regulatory patterns behind recent FDA CRLs
Identify high-risk areas that contribute to regulatory delays and non-approvable actions
Learn how an integrated regulatory and CMC strategy through a VDC model mitigates these risks
Apply lessons from CRLs to real-world planning for IND and BLA success
