The Food and Drug Administration'S Fast Track Designation: Observations from the Initial Two Years of this Designation

A new moniker for investigational drugs was introduced in the Food and Drug Administration Modernization Act (FDAMA), which became law in November 1997. This moniker, the “fast track designation,” is intended to offer a means for sponsors to propose, and FDA to officially recognize, that a specific investigational drug has demonstrated the potential to address an unmet medical need in the treatment of a serious or life-threatening condition. Such recognition is intended to facilitate development and expedite review of regulatory applications for fast track products (1). The purpose of this manuscript is to describe the fast track program. Information will be presented on the criteria to earn the fast track designation, benefits and challenges of the designation, and lessons learned from experiences reported in the public domain in the first two years that this designation has been available.