The Approval Failure Cascade
What happens to New Drug Applications — and why they fail
Common Reason #1
Inconsistencies in data presentation across the dossier
Common Reason #2
Failure to address previous regulatory questions comprehensively
Common Reason #3
Cross-references that no longer match after multi-jurisdiction adaptation
"These aren't scientific failures. They're storytelling failures."
Sources: Lu et al. (2019), n=825 NDAs | Avalere Health, 2018–2022 CRL analysis | PharmaSource (2025)