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Table 1 Comparison of the four FDA expedited programmes

From: Postmarketing safety of orphan drugs: a longitudinal analysis of the US Food and Drug Administration database between 1999 and 2018

Expedited programme Type Effect
Priority review Designation Reduces time of application review process from 10 to 6 months of priority regulatory review
Breakthrough therapy Designation Expedites review of drugs that may show substantial improvement for patients with serious diseases over existing drugs
Fast track Designation Expedites drug development and review to treat serious conditions and fill unmet medical need
Accelerated approval Approval pathway Permits use of surrogate or intermediate clinical endpoint for filling an unmet medical need for serious conditions