Number of Fast Track request actions granted or denied: 81

Median Fast Track request response time: 51 days

Fast Track programs are designed to facilitate the development and expedite the review of new drugs or biologics that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track emphasizes the critical nature of close, early communication between the FDA and sponsors. Procedures such as pre-IND and end-of-phase 1 meetings are convened as ways to improve the efficiency of pre-clinical and clinical development. These meetings can help FDA and sponsors reach early agreement on design of the major clinical efficacy studies that will be needed to support approval.

Under certain circumstances, FDA may consider reviewing portions of a marketing application in advance of the complete New Drug Application (NDA) or Biologic License Application (BLA). Fast Track products may also be eligible to participate in FDA’s Continuous Marketing Applications Pilot 1 or Pilot 2 programs.

Guidance for Industry Fast Track Development Programs

Draft Guidance for Industry Continuous Marketing Applications: Pilot 1

Draft Guidance for Industry Continuous Marketing Applications: Pilot 2