FDA Expanded Access – United States
FDA Form 3926 or sponsor/physician expanded access request materialsStatutory/Administrative
Description & Eligibility
The FDA expanded access pathway allows patients with serious or immediately life-threatening diseases to receive investigational drugs outside clinical trials when no comparable or satisfactory alternative therapy exists. Use requires that potential patient benefit justify the potential risks and that providing the drug will not interfere with clinical development. [4][5]
Eligibility Criteria
Patients with serious or immediately life-threatening conditions who cannot access a comparable or satisfactory approved therapy and for whom clinical trial enrollment is not possible.
Legal Reference / Source
21 CFR 312 Subpart I
FDA Expanded Access – United States
| Approval Form | FDA Form 3926 or sponsor/physician expanded access request materials |
| Legal Status | Statutory/Administrative |
| Source Ref. | 21 CFR 312 Subpart I |
| Countries | 0 countries |
Compliance Check
Legal Review7/24/2026
Global ValidityVerified