Table 1 Comparison of the four FDA expedited programmes
Expedited programme | Type | Effect |
|---|---|---|
Priority review | Designation | Reduces time of application review process from 10 to 6Â 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 |