ProGen Search Intelligence Tool
FDA Filing Diagnostic
ProGen Search published the first structured analysis of FDA Complete Response Letter patterns. This tool makes that research actionable. Answer 7 questions about your program and diagnose your FDA submission against 202 Complete Response Letters issued between 2007 and 2024.
This tool identifies historical patterns from public FDA correspondence. It does not predict approval outcomes or constitute regulatory advice.
Your Program
First-time FDA applicant?
Manufacturing and Inspection
Pre-approval facility inspection expected?
CMC and Clinical Readiness
CMC readiness checkpoints
Overall CMC readiness