728x90
| Category | Fast Track | Breakthrough Therapy | Accelerated Approval | Priority Review |
| Purpose | To expedite the availability of drugs for serious or life-threatening diseases | Applicable to drugs for serious conditions with limited treatment options |
Applied when there is significant benefit over existing therapies and can be demonstrated through surrogate endpoints |
For applications with prior approvals or modifications to existing approvals |
| Designation Criteria |
Rare or life-saving “innovative drugs" |
Treatment for serious conditions with unmet needs |
Drugs that can demonstrate effectiveness through surrogate markers and show substantial improvement over existing treatments |
For new applications or modifications to existing applications |
| Difference | Can be applied based on potential for treatment improvement |
Requires evidence of significant improvement in treatment |
Approval following an interim analysis after IND, pending FDA discussion |
Applied at NDA filing or upon additional data submission |
| Application Timing |
At IND submission or thereafter |
At IND submission or thereafter (near end of Phase 2) |
TBD, requires FDA discussion |
At NDA filing or upon additional data submission |
| Review Period |
Within 60 days of submission |
Within 60 days of submission |
- | Within 60 days of submission |
| Characteristics | Expedited development and review with rolling review |
- | - | Shortened marketing review time (10 months reduced to 6 months) |
| Reference |
1997 FDAMA Section 112 and 2012 FDASIA Section 901 |
FDASIA Section 902 and FD&C Act Section 506(a) |
21 CFR part 314, subpart H, and FD&C Act Section 506(c) |
1992 Prescription Drug User Fee Act (PDUFA) |
728x90