Approval programs & pathways
3 programs · 2 pathwaysExpedited / special pathways
Priority ReviewConditional ApprovalBreakthrough TherapyOrphan Drug
Priority ReviewExpedited
Accelerated review for innovative & urgently-needed drugs.
Eligibility · Innovation / clinical need
Conditional ApprovalConditional
Approval on early endpoints for serious conditions.
Eligibility · Serious disease + unmet need
Breakthrough TherapyExpedited
Designation for innovative drugs with notable clinical advantage.
Eligibility · Serious disease + preliminary evidence
Submission pathways · illustrative timelines & fees
IND2 mo
Biologics · Agency fee
Clinical trial application reviewed by CDE (60-working-day default approval).
NDA14 mo
Small molecules · Agency fee
Marketing authorization application via CDE.