Leveraging Expedited Programs for Drugs and Biologics for Serious Conditions and Rare Diseases

Posted 30 March 2015 By Diane M. Beatty, PhD

placeholder+image An analysis of the impact of FDA’s four expedited programs on development and review of drugs for serious conditions over the last two-and-a-half years since breakthrough therapy designation was introduced, including a performance summary.

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

Tags: Breakthrough therapy designation, fast track designation, priority review, accelerated approval pathway, unmet medical needs

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