FDA CDER FY2013, Initial INDs submitted and placed on hold
| All initial INDs | Initial INDs for rare diseases | Initial INDs for non-rare diseases | |
|---|---|---|---|
| Number of initial INDs submitted, n | 1410 | 211 | 1199 |
| Initial INDs active after first 30 days, n (%) | 1285 (91.1) | 186 (88.2) | 1099 (91.7) |
| Initial INDs placed on hold within first 30 days, n (%) | 125 (8.9) | 25 (11.8) | 100 (8.3) |
| Sponsor type | |||
| Commercial initial INDs submitted, n (%) | 705 (50.0) | 108 (51.2) | 597 (49.8) |
| Research initial INDs submitted, n (%) | 705 (50.0) | 103 (48.8) | 602 (50.2) |
| Commercial initial INDs on hold, n (%) | 60 (4.3) | 12 (5.7) | 48 (4.0) |
| Research initial INDs on hold, n (%) | 65 (4.6) | 13 (6.2) | 52 (4.3) |
IND, Investigational New Drug application.