FDA Pathway · Base-Rate Reference
Accelerated Approval FDA Base Rates
Historical first-cycle approval rates, typical time-to-decision, and AdCom frequency for Accelerated Approval submissions across 9 therapeutic-area indications. Approximate base rates for framing, not prediction.
What is Accelerated Approval?
Subpart H / Subpart E pathway for serious conditions using surrogate endpoints, with confirmatory post-marketing studies required.
Accelerated Approval base rates by indication
| Indication | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| Oncology | 85% | n~150 | priority 6 months | sometimes | Most accelerated approvals are oncology; increased FDA scrutiny on confirmatory trial timelines post-FDORA. |
| Rare Disease / Orphan | 75% | n~50 | priority 6 months | usually | Surrogate endpoint acceptance variable; AdComs increasingly convened for non-oncology rare disease. |
| Infectious Disease | 75% | n~25 | priority 6 months | sometimes | HIV and resistant-pathogen programs benefit from established virologic surrogates. |
| Immunology | 70% | n~15 | priority 6 months | sometimes | Rare autoimmune programs; acceptable biomarkers support most approvals. |
| Other | 70% | n~50 | priority 6 months | sometimes | FDA increasingly requires confirmatory trials enrolling at approval. |
| Cardiovascular | 60% | n~10 | priority 6 months | usually | Rarely used; surrogate-to-outcome validation typically required. |
| Endocrinology/Metabolic | 60% | n~15 | priority 6 months | usually | MASH/NASH and rare metabolic programs; surrogate-to-outcome translation closely scrutinized. |
| Neurology | 55% | n~20 | priority 6 months | usually | Surrogate acceptance contentious (e.g., amyloid, SMN); AdComs frequent and often split. |
| Psychiatry | 50% | n~5 | priority 6 months | usually | Very limited use; surrogate endpoints not well-established in psychiatry. |
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.
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Our live PDUFA calendar tracks upcoming FDA action dates across all Accelerated Approval and related submissions with sponsor, ticker, drug, and catalyst context.
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