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)

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