Table 1.
Reasons for Clinical Hold or Denial of Expanded Access INDs From 2005–2014.
| Reason | Clinical Hold, n | Denial, n |
|---|---|---|
| Incomplete application | 7 | |
| Unsafe dosing | 4 | |
| Lack of any demonstrated efficacy | 4 | |
| Availability of adequate alternative therapies | 3 | |
| Commercial IND on hold | 2 | |
| Product quality issues | 2 | |
| Inadequate safety monitoring | 1 | |
| Unreasonable risk | 1 | |
| Not an emergency | 21 | |
| Duplicate requests | 2 | |
| Unknowna | 15 | |
| Total | 24 | 38 |
All investigational new drugs (INDs) are subject to clinical hold, and only emergency IND requests for expanded access are subject to denial.
a
The absence of any documentation prohibited determination of reason for denial.