Expanded Access Program – USA
Form FDA 3926Statutory30 days
Description & Eligibility
FDA pathway allowing patients with serious diseases access to investigational drugs outside clinical trials. Requires manufacturer agreement and FDA approval.
Eligibility Criteria
Patients with serious/life-threatening conditions with no comparable alternatives
Legal Reference / Source
21 CFR 312.300
Expanded Access Program – USA
| Approval Form | Form FDA 3926 |
| Timeline | 30 days |
| Legal Status | Statutory |
| Source Ref. | 21 CFR 312.300 |
| Countries | 0 countries |
Compliance Check
Legal Review3/21/2026
Global ValidityVerified