FDA expedited review programs
| Program . | Features . |
|---|---|
| AA (confirmatory studies required) | End point is a surrogate reasonably likely to predict benefit |
| FT | Provides for rolling review |
| BTD | Intensive guidance from FDA and rolling review |
| Priority Review* | Review time 6 vs 10 mo standard review |
| Program . | Features . |
|---|---|
| AA (confirmatory studies required) | End point is a surrogate reasonably likely to predict benefit |
| FT | Provides for rolling review |
| BTD | Intensive guidance from FDA and rolling review |
| Priority Review* | Review time 6 vs 10 mo standard review |
Prescription Drug User Fee Act goal dates include an additional 2-mo filing period. For specific information, consult US Food and Drug Administration.3