Common Challenges in Drug Development for Non-Healing Chronic Wounds: Insights from FDA and WCCC Milestones

Chronic wound therapeutics face significant regulatory challenges, with many promising treatments failing to receive FDA approval despite positive preclinical data. This session will explore the most common regulatory pitfalls encountered during drug development for non-healing chronic wounds, drawing on FDA CDER's review experience and insights from the Wound Care Collaborative Community, WCCC. Attendees will learn about critical errors in clinical trial design, endpoint selection, and regulatory strategy that often hinder development programs. Understanding these frequent failure points can help developers design more robust trials and increase their chances of regulatory success in this challenging field. Additionally, attendees will learn about the substantial contributions of the WCCC in promoting innovation and enhancing patient access to advanced wound care.