Breakthrough TherapyExpedited
Intensive guidance & rolling review for therapies with preliminary clinical evidence of substantial improvement.
Eligibility · Serious condition + preliminary clinical evidence
Accelerated ApprovalExpedited
Approval on a surrogate endpoint reasonably likely to predict clinical benefit.
Eligibility · Serious condition + unmet need
Fast TrackExpedited
Facilitated development & rolling review for serious conditions.
Eligibility · Serious condition + nonclinical/clinical data
Orphan DrugOrphan
Incentives for drugs treating <200,000 US patients.
Eligibility · Rare disease prevalence
IND1 mo
Biologics · No fee
Investigational New Drug application to begin US clinical trials.
NDA10 mo
Small molecules · PDUFA program fee
New Drug Application for small-molecule marketing authorization.
BLA10 mo
Biologics · PDUFA program fee
Biologics License Application for biologics, vaccines & cell/gene therapies.
Orphan drug application3 mo
Rare diseases · No fee
Orphan-drug designation for rare-disease products.