FDA Pathway · Base-Rate Reference
Class 2 Resubmission FDA Base Rates
Historical first-cycle approval rates, typical time-to-decision, and AdCom frequency for Class 2 Resubmission submissions across 9 therapeutic-area indications. Approximate base rates for framing, not prediction.
What is Class 2 Resubmission?
Resubmission of an NDA/BLA after a Complete Response Letter — 6-month clock for Class 2 resubmissions where FDA requested a major deficiency fix.
Class 2 Resubmission base rates by indication
| Indication | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| Oncology | 75% | n~60 | 6 months from resubmission | sometimes | Class 2 resubmissions address major issues; second-cycle approvals common when CMC or data issues resolved. |
| Infectious Disease | 72% | n~30 | 6 months from resubmission | sometimes | Additional microbiology or resistance data commonly requested and readily addressed. |
| Rare Disease / Orphan | 70% | n~40 | 6 months from resubmission | sometimes | Additional data requests (confirmatory, CMC) drive resubmissions; generally successful when addressed. |
| Immunology | 70% | n~25 | 6 months from resubmission | sometimes | Most resubmissions resolve manufacturing or labeling issues and are approved. |
| Other | 65% | n~80 | 6 months from resubmission | sometimes | Aggregated across TAs; generally ~60-70% approved on first resubmission. |
| Endocrinology/Metabolic | 60% | n~20 | 6 months from resubmission | sometimes | CV safety CRLs can require new outcomes data. |
| Cardiovascular | 55% | n~20 | 6 months from resubmission | usually | Mortality/safety CRLs hardest to overcome without new trial data. |
| Psychiatry | 55% | n~15 | 6 months from resubmission | usually | Safety-focused CRLs can be difficult to resolve in a single resubmission. |
| Neurology | 50% | n~25 | 6 months from resubmission | usually | Efficacy-based CRLs often require new trials, reducing near-term resubmission success. |
Base rates drawn from published FDA approval analyses covering roughly 2008-2022. Cross-check against recent CDER/CBER reports for specific assets.
Run your specific pathway + indication combo
The full calculator lets you layer on designations (Breakthrough, Fast Track, Priority Review) and see how they shift base rate, time-to-decision, and AdCom likelihood.
Open the calculator →Who has upcoming Class 2 Resubmission dates?
Our live PDUFA calendar tracks upcoming FDA action dates across all Class 2 Resubmission and related submissions with sponsor, ticker, drug, and catalyst context.
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