FDA Pathway · Base-Rate Reference
NDA Priority FDA Base Rates
Historical first-cycle approval rates, typical time-to-decision, and AdCom frequency for NDA Priority submissions across 9 therapeutic-area indications. Approximate base rates for framing, not prediction.
What is NDA Priority?
Priority Review NDA — 6-month PDUFA clock for drugs offering significant improvements over existing therapy.
NDA Priority base rates by indication
| Indication | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| Oncology | 82% | n~200 | priority 6 months | sometimes | Priority review reflects unmet need; first-cycle approval rates notably higher than standard review. |
| Rare Disease / Orphan | 80% | n~150 | priority 6 months | sometimes | Strong first-cycle performance; CRLs typically CMC or confirmatory evidence adequacy. |
| Infectious Disease | 80% | n~60 | priority 6 months | sometimes | QIDP and LPAD pathways boost priority use; approvals typically first cycle with post-marketing commitments. |
| Immunology | 75% | n~40 | priority 6 months | sometimes | Priority often tied to serious autoimmune indications; approvals usually first cycle. |
| Other | 72% | n~120 | priority 6 months | sometimes | Aggregated across dermatology, ophthalmology, renal, and GI; priority usage uneven across TAs. |
| Cardiovascular | 70% | n~40 | priority 6 months | usually | Priority designations rarer; approvals tend to require robust outcomes data. |
| Endocrinology/Metabolic | 70% | n~30 | priority 6 months | sometimes | Rare metabolic diseases dominate priority; classic diabetes programs less often get priority. |
| Neurology | 65% | n~50 | priority 6 months | usually | ALS, rare pediatric, and Alzheimer's programs drive most priority filings; evidence debates common. |
| Psychiatry | 65% | n~25 | priority 6 months | usually | Priority granted for novel mechanisms; REMS common at approval. |
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 NDA Priority dates?
Our live PDUFA calendar tracks upcoming FDA action dates across all NDA Priority and related submissions with sponsor, ticker, drug, and catalyst context.
View 2026 PDUFA calendar →Related pathways
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