> ## Content Index
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# Guide on Drug Expedited Programs
- URL: https://www.fdaweb.com/guide-on-drug-expedited-programs/
- Published: 2017-09-25T12:00:00.000Z
- Updated: 2026-09-14T22:52:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139700

FDA has made available a [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf?ref=fdaweb.com) on “Expedited Programs for Serious Conditions — Drugs and Biologics.” The document outlines the four FDA programs — fast track designation, breakthrough therapy designation, accelerated approval and priority review designation — intended to facilitate and expedite development and review of new drugs to address unmet medical needs. It discusses the threshold criteria generally applicable to concluding that a drug is a candidate for these expedited development and review programs.