FDA’s Expedited Programs for Serious Conditions: An Overview

Posted 30 March 2015 By Diane M. Beatty, PhD

placeholder+image An overview of FDA’s four expedited drug development programs for serious or life-threatening conditions: fast track designation, breakthrough therapy designation, priority review designation and the accelerated approval pathway.

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Categories: Biologics and biotechnology, Drugs, Submission and registration, Features, US, FDA

Tags: Fast track designation, breakthrough therapy, priority review, accelerated approval, serious conditions, life-threatening conditions

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