The Fast Track designation increases communication between drug sponsors and the FDA throughout the development and review process for drugs that address unmet medical needs and treat serious or life-threatening conditions.


  • To be considered for Fast Track designation, a drug must address a serious or life-threatening condition and
  • The drug must demonstrate the potential to address unmet medical need. Depending on how far a drug is into development, this can mean mechanistic rationale, evidence of activity in a nonclinical model, pharmacological data, or clinical data indicating that the drug either treats a condition for which there exists no other treatment or provides some benefit over existing treatment.

When to Submit a Request:


  • Drug sponsors get extra opportunities to meet with the FDA and discuss study design, safety and efficacy requirements, dose-response concerns, use of biomarkers, and other critical development issues.
  • FDA may consider rolling review, allowing early review of portions of a drug sponsor’s marketing application before the complete application has been submitted.

Fast Track vs. Breakthrough Therapy:

  • Fast Track requirements are broader—While Breakthrough is only granted on the basis of clinical evidence, Fast Track can be granted based on nonclinical data
  • Fast Track has lower priority—the FDA commits greater resources and attention to handling Breakthrough drugs

The Perfect Candidate: Fast Track designation is best suited for promising drugs with the demonstrated potential to improve treatment of serious conditions that nevertheless lack the early clinical evidence or magnitude of effect required for Breakthrough Therapy designation.