1.7 — Fast Track / Special Designations

Requests for fast track, breakthrough therapy, accelerated approval, priority review, orphan drug, and pediatric designations

Requirements by Phase

IND Phase 1: optional IND Phase 2: optional IND Phase 3: optional NDA: required

Content Requirements

• Fast Track designation request with evidence of serious condition and unmet medical need
• Breakthrough Therapy designation request with preliminary clinical evidence of substantial improvement
• Accelerated Approval request with surrogate endpoint justification
• Priority Review request with evidence of significant improvement in safety or effectiveness
• Special Protocol Assessment request with proposed protocol and statistical analysis plan
• Orphan Drug designation request with prevalence data
• Pediatric designations and study plans

Expected Deliverables

• Designation request letter with supporting data

ICH Guidelines: FD&C Act Section 506, 21 CFR 312.80, FDA Expedited Programs Guidance

Source: FDA Expedited Programs Guidance