Fast Track Designation(Fast Track)
An FDA program designed to facilitate development and expedite review of drugs treating serious conditions and filling unmet medical needs.
Usage Examples
- The company received Fast Track designation for their Alzheimer's candidate.
- Fast Track enabled rolling submission of the BLA.
- FDA granted a Fast Track meeting to discuss the Phase 3 design.
What is Fast Track?
Fast Track is an FDA designation that facilitates the development and expedited review of drugs intended to treat serious or life-threatening conditions and that demonstrate potential to address unmet medical needs. The program was established under FDAMA (1997).
Benefits include more frequent meetings and communications with FDA, eligibility for rolling review (submitting completed sections before the entire application is finished), and potentially Priority Review and Accelerated Approval.
Fast Track designation can be requested at any time during development but is most valuable when requested before IND submission to maximize interaction benefits.
Regulatory Context
This term appears most often in submission & approval workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside FDAMA, 21 CFR 312.
When This Matters
- The company received Fast Track designation for their Alzheimer's candidate.
- Fast Track enabled rolling submission of the BLA.
- FDA granted a Fast Track meeting to discuss the Phase 3 design.
Common Mistakes
- Treating submission readiness as a formatting-only check without lifecycle validation.
- Using outdated guidance references across modules and summaries.
- Missing cross-functional review between RA, CMC, and quality before submission.
Related Regulations
Frequently Asked Questions
Rolling review allows sponsors to submit completed sections of an NDA/BLA for FDA review before the entire application is complete. This can shorten overall review time.
Yes, FDA can rescind Fast Track if subsequent data no longer support the designation criteria. However, this is relatively rare.
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Sources & References
