These checklists—now part of CDER’s Good Review Practices: Refuse to File (MAPP 6025.4)—give sponsors a clear roadmap to avoid “Refuse to File” (RTF) actions that can stall drug approvals, sometimes for more than 400 days. Over the past decade, more than 200 applications faced RTF setbacks due to preventable procedural gaps.
FDA Commissioner Dr. Marty Makary noted, “Drug applications should not be derailed or delayed by preventable procedural oversights,” while Dr. George Tidmarsh, CDER Director, emphasized that this release will “increase efficiency by eliminating preventable RTF actions.”
By aligning submissions with FDA’s own criteria, sponsors can build stronger applications, reduce resubmissions, and accelerate access to life-changing therapies.
