Status of initial INDs within one year after imposition of hold
| Initial INDs on hold | ||
|---|---|---|
| Rare diseases, n=25 | Non-rare diseases, n=100 | |
| Remain on hold, n (%) | 6 (24.0) | 49 (49.0) |
| Withdrawn, n (%) | 0 | 6 (6.0) |
| Hold removed, active, n (%) | 19 (76.0) | 45 (45.0) |
| Time to removal of hold (days)* | n=19 | n=45 |
| Mean | 129 | 107 |
| Median | 151 | 126 |
| Minimum, Maximum | 52,301 | 32,341 |
*For active applications only.
IND, Investigational New Drug application.