How to prepare Form FDA 3926 for individual patient expanded access

What is Form FDA 3926 used for?

Form 3926 supports specified physician-held individual-patient expanded-access IND submissions. Identify the physician’s transaction, patient initials, clinical rationale and treatment plan, reference authorization and applicable oversight requests. Keep the physician’s application separate from the manufacturer’s referenced IND; completing the form does not itself authorize treatment.

Before you begin

Preparation under the January 2025 Form 3926 instructions for an individual patient expanded-access IND. The treating physician makes clinical decisions. This is distinct from a general EUA request and does not itself establish patient eligibility or permission to treat.

What you will prepare: An accurately identified physician submission with an actual clinical plan, supported reference access and clearly resolved authorization and oversight steps.

Identify the physician’s transaction

Distinguish an initial request from follow-up and use the physician’s IND identifier where assigned, not the manufacturer’s referenced IND number. The instructions request patient initials rather than the full name. Use the actual submission date and physician contact information. Follow-up selections have their own field set; when the follow-up does not fit the listed categories, the instructions direct use of Form 1571.

Have the physician supply the rationale and plan

Organize the physician’s clinical history, prior treatment and response, reason other options are unsuitable, and proposed treatment. The plan needs the clinician’s dose rationale, administration, duration, monitoring and toxicity-response decisions. A writer can identify missing information and reconcile sources but must not invent a dose, eligibility finding or patient history. Keep the plan and supporting material identifiable so the physician can review the exact submission.

Resolve reference access and qualifications

Obtain the applicable authorization from the sponsor of the referenced IND. If unavailable, contact the relevant FDA review division about other information rather than claiming access that has not been granted. Include the physician’s qualification statement or appropriate CV evidence. Keep the manufacturer’s reference identifier separate from the physician-held application throughout the package.

Keep distinct authorizations and oversight decisions visible

The requests concerning use of Form 3926 and alternative IRB review procedures have different purposes. The latter requests chairperson or designated-member concurrence instead of a convened meeting; it does not remove IRB oversight. The physician commits to compliant informed consent and applicable IRB oversight. For nonemergency use, the certification specifies waiting 30 days after FDA receives the complete application unless FDA permits an earlier start; a clinical hold prevents starting or continuing treatment. Emergency use requires FDA authorization first, with the paperwork and applicable LOA due within 15 working days of that authorization. If emergency treatment proceeds without prior IRB approval, notify the IRB within 5 working days of treatment. Record the actual authorization, treatment and notification dates separately; a completed form is not permission.

Fictional example: an authorization does not identify the applicant

A manufacturer sends an LOA showing its own IND, and that number is copied into the physician’s application field. Separate the two records and resolve the physician’s assigned identifier with the actual application history. If the LOA is absent, preserve the missing-reference issue and seek the division’s direction. Do not fabricate an authorization or broaden its scope to make the package appear complete.

Keep reference permission, treatment authorization and oversight separate

Use a preparation record that names the actual evidence for each decision. This organizes the physician’s information; it does not make a clinical eligibility or treatment decision.

Record exercise: the emergency authorization date and treatment date differ. Keep them as separate events because the instructions tie subsequent actions to different triggers. Have the responsible team verify the applicable deadlines from the actual circumstances rather than placing every follow-up on one copied calendar date.

For follow-up outside the categories listed in the 3926 instructions, assess the 1571 route specified there. Use the form-selection guide when the request instead concerns a sponsor program or another expanded-access category.

Before execution, give the physician the full plan and supporting records, with unresolved items plainly identified. A polished narrative cannot supply missing authorization, oversight or clinical judgment.

Frequently asked questions

Sources and revisions

Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.

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