Definition
Fast Track Designation is an FDA program designed to expedite development and review of drugs that treat serious conditions and fill an unmet medical need. Established by the FDA Modernization Act of 1997, it provides sponsors with enhanced FDA engagement throughout development.
How Fast Track Works
Sponsors request Fast Track designation at any point during development. FDA evaluates whether the drug addresses a serious condition with no adequate therapy or offers advantages over available treatments.
Eligibility Criteria
- Treats a serious or life-threatening condition
- Demonstrates potential to address unmet medical need
- May be based on nonclinical or early clinical data
- Can be requested before IND submission
Fast Track Benefits
| Benefit | Description |
|---|---|
| Frequent Meetings | More opportunities for FDA guidance |
| Written Communication | FDA feedback on development plans |
| Rolling Review | Submit application sections as completed |
| Accelerated Approval Eligibility | May qualify for surrogate endpoint approval |
| Priority Review Eligibility | May qualify for 6-month review |
Expedited Program Comparison
| Feature | Fast Track | Breakthrough | Priority Review | Accelerated |
|---|---|---|---|---|
| More FDA Meetings | Yes | Yes | No | No |
| Rolling Review | Yes | Yes | No | No |
| 6-Month Review | Eligible | Eligible | Yes | Eligible |
| Surrogate Endpoints | Eligible | Eligible | No | Yes |
Why BD Teams Track Fast Track
For business development professionals, Fast Track status signals expedited programs:
- Deal Implication: Fast Track reduces development risk and may accelerate timeline to approval
- Due Diligence Focus: Verify FDA has granted designation and understand unmet need rationale
- Opportunity Signal: Fast Track programs attract investor attention and partnership interest