The following four FDA programs are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition: fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation (see Section IV for an overview of the programs). This guidance for industry provides a single resource for information on FDA’s policies and procedures for these four programs as well as threshold criteria generally applicable to concluding that a drug is a candidate for these expedited development and review programs.
The provisions of this guidance, when finalized, will replace the current guidance for industry entitled Fast Track Drug Development Programs—Designation, Development, and Application Review (issued January 2006). The provisions of this guidance relating to available therapy, when finalized, will replace the current guidance for industry entitled Available Therapy (issued 26 July 2004).
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.