Initial INDs on hold by reason
| Initial INDs on hold | |||
|---|---|---|---|
| Discipline | All, n=125 | Rare diseases, n=25 | Non-rare diseases, n=100 |
| Clinical, n (%) | 34 (27.2) | 7 (28.0) | 27 (27.0) |
| Product quality, n (%) | 35 (28) | 5 (20.0) | 30 (30.0) |
| Toxicology, n (%) | 17 (13.6) | 4 (16.0) | 13 (13.0) |
| Clinical and product quality, n (%) | 14 (11.2) | 4 (16.0) | 10 (10.0) |
| Clinical and toxicology, n (%) | 10 (8) | 2 (8.0) | 8 (8.0) |
| Product quality and toxicology, n (%) | 5 (4) | 1 (4.0) | 4 (4.0) |
| Clinical, product quality and toxicology, n (%) | 6 (4.8) | 0 | 6 (6.0) |
| Device, n (%) | 1 (0.8) | 1 (4.0) | 0 |
| Clinical and device, n (%) | 2 (1.6) | 1 (4.0) | 1 (1.0) |
| Clinical, device and toxicology, n (%) | 1 (0.8) | 0 | 1 (1.0) |
IND, Investigational New Drug application.