Fast Track

Designation given by the FDA to programs that are designed to facilitate the development and expedite the review of new drugs 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 sponsor, procedures such as pre-IND and end of Phase I meetings as methods to improve the efficiency of preclinical and clinical development, and focuses on efforts by the FDA and sponsor to reach early agreement on the design of the major clinical efficacy studies that will be needed to support approval.