Tip for FDA Form 3926

For life-threatening emergencies, call the FDA Emergency Line at 1-855-543-3784 — authorization can be granted by phone

Tip for FDA Form 3926

The drug manufacturer must agree to provide the drug — FDA approval alone is not sufficient

Tip for FDA Form 3926

Form 3926 is significantly simplified compared to the traditional IND application

Clinical TrialshardDoctor signature required

Individual Patient Expanded Access IND Application

FDA Form 3926 · U.S. Food and Drug Administration

Simplified form for requesting compassionate use of investigational drugs for patients with serious or life-threatening conditions and no alternatives. FDA approves over 99% of requests. Requires manufacturer agreement to provide the drug.

Form Details

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Where to Submit This Form

🌐

Submit electronically through the FDA's Electronic Submission Gateway

https://www.fda.gov/industry/electronic-submissions-gateway

Individual Patient Expanded Access IND applications can be submitted electronically.

📬

Mail to the FDA Center for Drug Evaluation and Research

Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

📠

Fax for emergency expanded access requests

For emergency situations, the FDA can authorize treatment by phone (1-855-543-3784) and accept the written submission within 15 working days.

Filing Deadline

Emergency requests: FDA can authorize by phone within hours. Non-emergency individual patient requests: submit before treatment begins. FDA aims to respond within 30 days for non-emergency requests.

Required Attachments

📎 Completed FDA Form 3926 (Individual Patient Expanded Access IND)
📎 Letter of authorization from the drug manufacturer agreeing to provide the drug
📎 Brief clinical summary of the patient's condition and treatment history
📎 Justification for why no comparable alternative therapy is available
📎 Treating physician's qualifications

Processing Time

Emergency: same-day phone authorization, written follow-up within 15 working days. Non-emergency: FDA aims to respond within 30 days.

What Happens Next

If authorized, the treating physician can obtain the investigational drug from the manufacturer and administer it to the patient. An IRB must review the use (may occur after treatment initiation for emergencies). Adverse event reporting is required.

Tips for This Form

✓ For life-threatening emergencies, call the FDA Emergency Line at 1-855-543-3784 — authorization can be granted by phone
✓ The drug manufacturer must agree to provide the drug — FDA approval alone is not sufficient
✓ Form 3926 is significantly simplified compared to the traditional IND application
✓ Your treating physician submits this form — patients do not submit it directly

More Clinical Trials Forms

Informed Consent Document (ICF)

Study-specific · Study sponsor / institution

Comprehensive document explaining the clinical trial: purpose, procedures, risks, benefits, alternatives, voluntariness, and right to withdraw. Must be approved by IRB.

HIPAA Authorization for Research

Institution-specific · Research institution

Separate authorization for use and disclosure of PHI for research purposes. May be broader than clinical HIPAA authorization.

Eligibility Screening / Inclusion-Exclusion Checklist

Study-specific · Study sponsor

Checklist confirming the participant meets all inclusion criteria and no exclusion criteria for the clinical trial.

Investigational New Drug Application (IND)

FDA Form 1571 · U.S. FDA

Traditional IND application form for expanded access submissions. Form 3926 is the simplified alternative for individual patients.

Statement of Investigator

FDA Form 1572 · U.S. FDA

Statement of investigator qualifications and commitment to conduct the study per FDA regulations. Accompanies IND submissions.

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