FDA Pathway · Base-Rate Reference
NDA Standard FDA Base Rates
Historical first-cycle approval rates, typical time-to-decision, and AdCom frequency for NDA Standard submissions across 9 therapeutic-area indications. Approximate base rates for framing, not prediction.
What is NDA Standard?
Standard New Drug Application — the default 10-month PDUFA pathway for small-molecule drugs without Priority Review designation.
NDA Standard base rates by indication
| Indication | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| Rare Disease / Orphan | 72% | n~120 | standard 10 months | sometimes | Higher first-cycle approvals due to orphan flexibility on endpoints; CRLs often CMC-related. |
| Oncology | 70% | n~150 | standard 10 months | sometimes | Approvals increasingly tied to biomarker-defined populations; CRLs often driven by manufacturing/CMC or confirmatory trial design. |
| Infectious Disease | 70% | n~90 | standard 10 months | sometimes | Non-inferiority designs common; resistance data and QIDP status influence reviews. |
| Immunology | 65% | n~80 | standard 10 months | sometimes | Well-characterized endpoints support approval; safety labeling tends to be the main negotiation. |
| Endocrinology/Metabolic | 60% | n~70 | standard 10 months | sometimes | CV outcomes trials often required post-approval; CRLs frequently cite long-term safety. |
| Other | 60% | n~200 | standard 10 months | sometimes | Aggregated across derm, ophthalmology, GI, GU, and renal; heterogeneous outcomes. |
| Cardiovascular | 55% | n~60 | standard 10 months | usually | Large outcomes trials required; CRLs frequently cite CV safety or underpowered mortality benefit. |
| Psychiatry | 55% | n~50 | standard 10 months | usually | Placebo response and suicidality signals drive AdComs; REMS often required at approval. |
| Neurology | 50% | n~70 | standard 10 months | usually | Endpoint validity and effect size commonly challenged; historically high CRL rate outside rare neuro indications. |
Base rates drawn from published FDA approval analyses covering roughly 2008-2022. Cross-check against recent CDER/CBER reports for specific assets.
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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.
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