FDA Pathway · Base-Rate Reference
Fast Track FDA Base Rates
Historical first-cycle approval rates, typical time-to-decision, and AdCom frequency for Fast Track submissions across 9 therapeutic-area indications. Approximate base rates for framing, not prediction.
What is Fast Track?
Designation expediting review for drugs addressing unmet medical need in serious conditions — includes rolling submission.
Fast Track base rates by indication
| Indication | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| Infectious Disease | 78% | n~60 | priority 6 months | sometimes | QIDP + Fast Track pairing common; approval rates robust. |
| Oncology | 72% | n~200 | varies; often priority 6 months | sometimes | Fast Track enables rolling review; approval rates higher than non-designated peers but below Breakthrough. |
| Rare Disease / Orphan | 72% | n~120 | varies; often priority 6 months | sometimes | Widely used in rare disease; commonly paired with orphan and often accelerated approval. |
| Immunology | 72% | n~40 | standard 10 months | sometimes | Used for serious autoimmune indications; generally favorable approval rates. |
| Other | 68% | n~150 | standard 10 months | sometimes | Fast Track alone is a weaker approval predictor than Breakthrough or Priority. |
| Endocrinology/Metabolic | 65% | n~25 | standard 10 months | sometimes | Rare metabolic and NASH programs most common; long-term safety remains the review hurdle. |
| Cardiovascular | 60% | n~30 | standard 10 months | usually | Fast Track improves communication cadence but outcomes-trial requirements persist. |
| Psychiatry | 60% | n~20 | standard 10 months | usually | Used for novel CNS mechanisms; REMS common. |
| Neurology | 55% | n~40 | standard 10 months | usually | Designation frequent but approval outcomes still depend on effect size debates. |
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 Fast Track dates?
Our live PDUFA calendar tracks upcoming FDA action dates across all Fast Track and related submissions with sponsor, ticker, drug, and catalyst context.
View 2026 PDUFA calendar →Related pathways
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