Understanding FDA’s reasons for nonapproval: A systematic review of complete response letters in cell and gene therapy

Overview

ElevateBio’s Cindy Riggins, Vice President, CMC Regulatory Affairs, and Eugene Babcock, Director, Regulatory, have authored a new article in Cytotherapy examining FDA Complete Response Letters (CRLs) for cell and gene therapies. This valuable analysis highlights common regulatory themes and key considerations to help partners strengthen their development strategies and prepare more robust submissions from the start. The findings reinforce the importance of comprehensive CMC readiness and early inspection preparation to reduce regulatory risk and improve approval outcomes, an approach that reflects how ElevateBio works with partners to anticipate challenges early and build regulatory success into every stage of development

View Article