Issue Date: May 30, 2014
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final
Expedited Programs for Serious Conditions | Drugs and Biologics
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 lifethreatening condition: fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation (see section IV for an overview of the programs). The purpose of this guidance for industry is to provide 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.
Download the Guidance Document
