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Form FDA 3926: Single Patient Expanded Access IND

To treat one patient with an investigational drug or biologic outside a clinical trial, often called compassionate use, a treating physician can request an individual patient expanded access IND on this streamlined FDA form. The physician acts as sponsor, describes the patient and treatment plan, attaches the manufacturer's letter of authorization, and certifies IRB and informed consent obligations.

Who completes it

The treating physician completes the whole form as sponsor-investigator: physician details, patient initials, clinical history, treatment plan, letter of authorization, qualifications, and the certification in item 11, which the physician signs.

Submitting and payment

How to submit it
The physician submits the form to FDA following FDA's 'Expanded Access - How to Submit' instructions referenced on the form; treatment waits 30 days after FDA receipt unless FDA authorizes it sooner.

Good to know

  • In an emergency, treatment may begin without prior IRB approval, provided the IRB is notified within 5 working days of treatment.
  • Item 10.a requests permission to use Form FDA 3926 instead of the full IND forms; item 10.b can request IRB chair or designated-member concurrence instead of a convened meeting.
  • Follow-up submissions (safety reports, annual report, summary when treatment ends) use the same form under item 4.b; other follow-ups use Form FDA 1571.
  • Current edition 01/25, 3 pages, OMB 0910-0814 (expires 10/31/2026), an encrypted fillable PDF.

Get the official form

Download the current version from the source each time; forms change without notice.

Individual Patient Expanded Access Investigational New Drug Application (IND)

Official pagePDF

How this list is checked

A form is listed only after its name and number were confirmed on the issuing agency’s or insurer’s own website, or in the form itself. Each entry links to that source. The list was last checked in October 2026. Forms and their requirements change without notice, so check the official page for the current version before you complete one.

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Frequently asked questions

What does a physician need before submitting Form FDA 3926?

Usually a letter of authorization from the manufacturer that will supply the drug, attached in item 7, plus the patient's clinical history, a treatment plan with dose, route, schedule, duration, monitoring and toxicity modifications, and a qualification statement or the first pages of the physician's CV.

How soon can treatment start after submitting Form FDA 3926?

The physician certifies not to begin treatment until 30 days after FDA receives a complete application unless FDA gives earlier notice that treatment may begin. For emergencies, treatment may begin without prior IRB approval as long as the IRB is notified within 5 working days.

Can Form FDA 3926 be used for follow-up reports?

Yes. Checking 4.b marks a follow-up to an existing individual patient IND, and item 9 lists what is attached: IND safety reports, an annual report, a summary of expanded access use once treatment is completed, a change in treatment plan or other correspondence. If none apply, the physician uses Form FDA 1571.