Indication · Base-Rate Reference
Psychiatry FDA Approval Rates
Historical first-cycle FDA approval rates for Psychiatry assets across 8 regulatory pathways — NDA Standard, NDA Priority, BLA, sBLA, Class 2 Resubmission, Accelerated Approval, Breakthrough Therapy, Fast Track.
What's specific about Psychiatry at FDA?
Placebo response rates are high; separation from placebo often drives regulatory uncertainty. AdComs are common for new mechanisms (e.g., psychedelics, first-in-class antidepressants).
Psychiatry base rates by pathway
| Pathway | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| sBLA | 75% | n~15 | standard 10 months | sometimes | Expansions into adjacent indications generally successful when safety maintained. |
| Breakthrough Therapy | 70% | n~10 | priority 6 months | usually | Used for postpartum depression, TRD psychedelics, and similar; REMS common. |
| NDA Priority | 65% | n~25 | priority 6 months | usually | Priority granted for novel mechanisms; REMS common at approval. |
| Fast Track | 60% | n~20 | standard 10 months | usually | Used for novel CNS mechanisms; REMS common. |
| NDA Standard | 55% | n~50 | standard 10 months | usually | Placebo response and suicidality signals drive AdComs; REMS often required at approval. |
| BLA | 55% | n~10 | standard 10 months | usually | Few biologics in psychiatry; safety and class-effect extrapolation dominate review. |
| Class 2 Resubmission | 55% | n~15 | 6 months from resubmission | usually | Safety-focused CRLs can be difficult to resolve in a single resubmission. |
| Accelerated Approval | 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. Approximate — use as framing, not prediction.
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