Indication · Base-Rate Reference
Infectious Disease FDA Approval Rates
Historical first-cycle FDA approval rates for Infectious Disease assets across 8 regulatory pathways — NDA Standard, NDA Priority, BLA, sBLA, Class 2 Resubmission, Accelerated Approval, Breakthrough Therapy, Fast Track.
What's specific about Infectious Disease at FDA?
Accelerated Approval is common for antimicrobial resistance. CBER review for most vaccines; CDER for antivirals and antibiotics.
Infectious Disease base rates by pathway
| Pathway | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| sBLA | 85% | n~50 | priority 6 months | rarely | Pediatric indications, new pathogens, and combination claims typically approved first cycle. |
| Breakthrough Therapy | 85% | n~30 | priority 6 months | rarely | HIV and HCV breakthrough programs historically approved first cycle. |
| NDA Priority | 80% | n~60 | priority 6 months | sometimes | QIDP and LPAD pathways boost priority use; approvals typically first cycle with post-marketing commitments. |
| Fast Track | 78% | n~60 | priority 6 months | sometimes | QIDP + Fast Track pairing common; approval rates robust. |
| Accelerated Approval | 75% | n~25 | priority 6 months | sometimes | HIV and resistant-pathogen programs benefit from established virologic surrogates. |
| BLA | 72% | n~50 | priority 6 months | sometimes | Monoclonals and vaccines; EUA-to-BLA conversions common and generally successful. |
| Class 2 Resubmission | 72% | n~30 | 6 months from resubmission | sometimes | Additional microbiology or resistance data commonly requested and readily addressed. |
| NDA Standard | 70% | n~90 | standard 10 months | sometimes | Non-inferiority designs common; resistance data and QIDP status influence reviews. |
Base rates drawn from published FDA approval analyses covering roughly 2008-2022. Approximate — use as framing, not prediction.
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