FDA seeks November 9 comments on expanded-access form revisions
Oct 11, 2026 edition · GC-2026-0310 · Published 2026-10-11 · Version 3 · Proposed
FDA seeks November 9 comments during OMB review of individual-patient expanded-access form changes. The proposal revises treatment-initiation and follow-up fields, with instructions changing upon OMB approval and continued use of the existing form options expressly preserved.
What happened
FDA's October 9 notice submits an expanded-access information-collection revision for OMB review, with comments due November 9. In Form 3926 Field 6, the investigational-drug-name element would be replaced by the planned treatment-initiation date, and the FDA review-division element would identify the office/review division if known. Field 9's heading would specify follow-up or additional submissions only. FDA says accompanying instructions will be revised upon OMB approval, rather than describing approval as already completed.
The collection supports licensed physicians requesting individual-patient treatment access to investigational products for serious or immediately life-threatening conditions when no comparable satisfactory alternative is available. The notice permits continued use of Form 3926 or Form 1571 to satisfy the identified IND submission requirements. A physician-signed Form 3926 with the Field 10.a authorization box checked is treated as the specified waiver request under 21 CFR 312.10. These form procedures do not themselves grant treatment access or replace the separate clinical and regulatory criteria governing an expanded-access decision.
Scope and timing
- Authority status
- Proposed
- Applicability
- Potentially applicable
- Audience
- Health systems, Provider networks
- Jurisdiction
- Federal
- Recorded date
- 2026-11-09
- Date type
- comment
Why it matters
The form supports licensed physicians requesting individual-patient expanded access. Instructions would change upon OMB approval; the notice permits continued use of Forms 3926 or 1571. It does not itself authorize treatment or change clinical eligibility.
Recommended action
Research and pharmacy owners should compare expanded-access templates with the proposed fields, consider comments by November 9 and monitor OMB approval before revising required forms.
Sources
- Expanded access to investigational drugs: information collection revisionOfficial · FDA · 2026-10-09 · Source review 2026-10-11
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