Expedited programs for serious conditions
| Program . | Description . |
|---|---|
| Fast track designation | Drug or treatment must provide theoretical rationale, mechanistic rationale, or evidence of nonclinical activity in the targeted disease or condition. |
| Breakthrough therapy designation | Drug or treatment must provide preliminary clinical evidence of a treatment effect, ie, substantially greater than that of available therapies. |
| Accelerated approval | Drug or treatment must show substantially improved benefit over the available standard of care via either of 2 primary end points: (1) a surrogate end point or biomarker or (2) an intermediate clinical end point. Continued approval is contingent upon confirmatory trials. |
| Priority review designation | FDA commits to review the marketing application for a study drug within 6 months compared with the average 10 months for the standard approval pathway. |
| Orphan drug designation | Separate from the expedited program pathway. Drug that targets a rare disease/condition; in the United States, defined as affecting <200 000 individuals. |
| Program . | Description . |
|---|---|
| Fast track designation | Drug or treatment must provide theoretical rationale, mechanistic rationale, or evidence of nonclinical activity in the targeted disease or condition. |
| Breakthrough therapy designation | Drug or treatment must provide preliminary clinical evidence of a treatment effect, ie, substantially greater than that of available therapies. |
| Accelerated approval | Drug or treatment must show substantially improved benefit over the available standard of care via either of 2 primary end points: (1) a surrogate end point or biomarker or (2) an intermediate clinical end point. Continued approval is contingent upon confirmatory trials. |
| Priority review designation | FDA commits to review the marketing application for a study drug within 6 months compared with the average 10 months for the standard approval pathway. |
| Orphan drug designation | Separate from the expedited program pathway. Drug that targets a rare disease/condition; in the United States, defined as affecting <200 000 individuals. |