FDA Form 3926 is a streamlined, two-page application that licensed physicians use to request expanded access to investigational drugs for individual patients with serious or life-threatening conditions. This form, officially called the “Individual Patient Expanded Access – Investigational New Drug Application (IND),” simplifies what was once a complex process requiring multiple forms. The FDA designed Form 3926 specifically to make compassionate use requests easier for physicians who treat patients with no other treatment options.
The approval rate for expanded access requests is remarkably high—over 99% of requests receive FDA authorization, with median response times of less than one day for emergency requests and approximately four days for non-emergency submissions. Despite these favorable statistics, many physicians remain unfamiliar with the proper procedures, leading to unnecessary delays or incomplete applications.
In this article, you will learn:
📋 How to complete every field on Form FDA 3926 step-by-step, including the specific information required and formatting rules
⚕️ The difference between emergency and non-emergency expanded access requests and which process applies to your patient’s situation
📝 Common mistakes that cause clinical holds and how to avoid them when preparing your submission
🏥 IRB review requirements and how to request a waiver for full board review using Field 10.b
💊 How to obtain a Letter of Authorization from drug manufacturers and what to do if one is not available
What Is FDA Form 3926 and When Do You Use It?
FDA Form 3926 serves as the primary application for physicians seeking to treat individual patients with investigational drugs outside of clinical trials. The form consolidates what previously required submission of Forms FDA 1571 and 1572, reducing the paperwork burden significantly. Physicians can complete Form 3926 in approximately 45 minutes, compared to several hours for traditional IND submissions.
The form applies to both emergency and non-emergency situations. Emergency use refers to cases where immediate treatment is needed before a written submission can be made—the FDA can authorize treatment over the phone in these circumstances. Non-emergency use covers situations where there is sufficient time to submit the written application and wait for FDA review.
Form 3926 does not apply to expanded access for intermediate-size patient populations or widespread treatment use. Those categories still require submission of Forms FDA 1571 and 1572. Similarly, medical device expanded access uses different procedures and forms.
Patient Eligibility Requirements for Expanded Access
Before completing Form 3926, the physician must confirm the patient meets all eligibility criteria established by FDA regulations under 21 CFR 312.305 and 312.310. These criteria protect patients while ensuring appropriate use of investigational products.
| Eligibility Criterion | What This Means for Your Patient |
|---|---|
| Serious or life-threatening condition | Patient has a disease with substantial impact on daily functioning OR reasonable likelihood of death within months |
| No comparable alternative therapy | Standard treatments have failed, are not tolerable, or do not exist for the patient’s condition |
| Risk-benefit justification | Potential benefit from the investigational drug outweighs its potential risks |
| Cannot access through clinical trial | Patient is ineligible for or cannot practically enroll in existing trials |
| Treatment won’t compromise drug development | Providing access won’t interfere with ongoing studies needed for FDA approval |
The physician—not the patient or family—must make these determinations based on clinical judgment. Patients cannot apply for expanded access themselves; only a licensed physician overseeing the patient’s care may submit the request.
Step-by-Step Instructions for Every Field on Form 3926
Field 1: Physician’s Name, Institution, and Contact Information
Enter your full legal name as it appears on your medical license. Include the name of your hospital, clinic, or practice. Provide complete contact information including physical address, email, telephone number, and fax number.
Why this matters: The FDA uses this information to communicate about your application and assign the IND number. Incorrect contact information can delay authorization notifications or prevent the FDA from reaching you with questions.
Field 2: Patient’s Initials
Enter only the patient’s initials—not the full name. This preserves patient confidentiality in regulatory documents. The patient does not need to sign or initial the form themselves.
Field 3: Date of Submission
Provide the date in mm/dd/yyyy format. For emergency follow-up submissions, this date starts the 15-working-day timeline for required paperwork after initial phone authorization.
Field 4: Type of Submission
This field determines which other sections you must complete.
Field 4.a. (Initial Submission): Check this box if you are submitting a new expanded access request, including emergency requests. Complete Fields 5-8 and Fields 10-11. If the FDA previously issued you an IND number for another expanded access request, enter it here—but do not enter the drug manufacturer’s commercial IND number.
Field 4.b. (Follow-Up Submission): Check this box for submissions to an existing expanded access IND. Enter the investigational drug name and the IND number the FDA assigned to your expanded access application. Complete Fields 9-11 only.
Field 5: Clinical Information
This section requires a comprehensive picture of your patient’s condition and treatment history. Include:
- Patient demographics: Age, sex, weight
- Allergies and sensitivities: Both general (such as soy) and drug-specific
- Race and ethnicity: As reported by the patient (optional but helpful)
- Diagnosis: Summary of relevant medical history, diagnostic procedures, disease stage, and functional status
- Prior therapy: List previous treatments attempted
- Response to prior therapy: Example: “Patient received Drug X and subsequently developed lung metastasis”
- Reason for request: Explain why this patient lacks other options (e.g., “Patient has failed three lines of chemotherapy and is ineligible for registered trials at ClinicalTrials.gov”)
Common mistake: Providing vague statements like “patient has tried everything.” Instead, list specific treatments and their outcomes. Detailed clinical histories help FDA reviewers understand the medical necessity and process your request faster.
Field 6: Treatment Information
Provide specific details about how you plan to use the investigational drug:
| Required Element | Example |
|---|---|
| Drug name | Investigational compound ABC-123 |
| Manufacturer/supplier | XYZ Pharmaceuticals |
| Applicable FDA review division | Office of Oncologic Diseases (if known) |
| Dose | 200 mg |
| Route of administration | Intravenous infusion |
| Schedule | Once weekly for 12 weeks |
| Planned treatment duration | 3 months with possible extension based on response |
| Monitoring procedures | Weekly CBC, monthly liver function tests, MRI at baseline and week 8 |
| Toxicity management | Dose reduction to 150 mg for Grade 3 adverse events; hold treatment for Grade 4 |
You may attach an Investigator’s Brochure or relevant scientific publications to support your treatment plan. The rationale for your chosen dose is particularly important if you are using a dose different from that studied in clinical trials.
Field 7: Letter of Authorization (LOA)
The LOA grants FDA permission to reference the drug manufacturer’s existing IND for information about chemistry, manufacturing, controls, pharmacology, and toxicology. This eliminates the need for you to provide this complex technical information yourself.
How to obtain an LOA: Contact the drug manufacturer directly and request they provide a letter authorizing FDA to reference their IND. The LOA should include the manufacturer’s IND number. Many pharmaceutical companies have formal expanded access policies available on their websites or through the Reagan-Udall Foundation’s Expanded Access Navigator.
If an LOA is unavailable: Some manufacturers do not have an IND filed with FDA, or may decline to provide authorization. In these cases, contact the appropriate FDA review division directly before submission to determine what alternative information will satisfy requirements.
Field 8: Physician’s Qualification Statement
Establish your qualifications to administer the investigational treatment. Include:
- Medical school attended and year of graduation
- Medical specialty
- State medical license number
- Current employer
- Job title
Alternatively, you may attach the first few pages of your curriculum vitae if they contain this information. The FDA wants assurance that a qualified physician will supervise the patient’s treatment and monitor for adverse events.
Field 9: Contents of Submission (Follow-Up Only)
This field applies only to follow-up submissions after your initial expanded access IND is established. Check all boxes that apply to your submission:
Box 1 – Initial Written IND Safety Report: Submit within 15 calendar days of determining a serious and unexpected adverse event qualifies for reporting, or within 7 calendar days for fatal or life-threatening suspected reactions.
Box 2 – Follow-up to a Written Safety Report: Additional information about a previously reported adverse event. Submit within 15 calendar days of receiving new information.
Box 3 – Annual Report: Due within 60 days of the anniversary date your IND became active. Not required if treatment concluded and FDA was notified before one year passed.
Box 4 – Summary of Expanded Access Use: Required when treatment is complete. Include outcomes and any adverse effects experienced.
Box 5 – Change in Treatment Plan: Protocol amendments such as dose modifications or changes in monitoring procedures.
Box 6 – General Correspondence: Administrative communications not covered by other categories.
Box 7 – Response to FDA Request for Information: Answers to specific questions the FDA has asked about your application.
Box 8 – Response to Clinical Hold: Your submission addressing concerns that caused FDA to place your IND on hold.
Field 10.a: Request to Use Form 3926
Check this box to request that FDA accept Form 3926 as your complete IND submission. This constitutes a waiver request under 21 CFR 312.10 for any additional requirements normally associated with IND applications. FDA considers this waiver appropriate because compliance with additional requirements is unnecessary for evaluating individual patient expanded access.
Field 10.b: Request for Alternative IRB Review
Check this box if you want to request a waiver from full IRB board review. When checked, this serves as your formal request under 21 CFR 56.105 to have the IRB chairperson or a designated IRB member provide concurrence instead of convening a full board meeting.
Important: Do not check this box for emergency expanded access requests. Field 10.b is for non-emergency situations where you want streamlined IRB review before treatment begins. Emergency use is already exempt from prior IRB approval—you simply notify the IRB within 5 working days after treatment starts.
Field 11: Certification and Signature
Sign and date the form to certify that you:
- Will not begin treatment until 30 days after FDA receives your submission (or earlier with FDA notification)
- Agree not to continue treatment if FDA places the IND on clinical hold
- Will obtain informed consent per 21 CFR Part 50 requirements
- Will ensure IRB review and approval consistent with 21 CFR Part 56
- Will conduct treatment in accordance with all applicable regulations
For emergency requests, your signature acknowledges that treatment may begin without prior IRB approval provided you notify the IRB within 5 working days.
Three Real-World Scenarios: Action and Outcome
Scenario 1: Dr. Martinez’s Non-Emergency Request
Dr. Martinez treats Maria, a 58-year-old woman with advanced ovarian cancer who has failed four lines of chemotherapy. A promising investigational drug shows activity against her tumor’s specific mutation, but the Phase 3 trial excludes patients with her level of prior treatment.
| Action Dr. Martinez Takes | Resulting Outcome |
|---|---|
| Contacts manufacturer for LOA | Receives authorization within 3 business days |
| Completes Form 3926 Fields 1-8 and 10-11 | Submits via secure email to FDA review division |
| Checks Field 10.b for IRB waiver | IRB chair provides concurrence within 48 hours |
| Waits for FDA notification | FDA allows treatment to proceed on day 4 |
| Obtains informed consent from Maria | Documents Maria’s understanding of experimental nature |
| Begins treatment | Maria starts therapy under close monitoring |
Scenario 2: Dr. Chen’s Emergency Request
Dr. Chen has a patient, Robert, with rapidly progressive ALS who is experiencing respiratory failure. An investigational neuroprotective drug may slow decline, but Robert cannot wait for written submissions.
| Action Dr. Chen Takes | Resulting Outcome |
|---|---|
| Calls FDA Emergency Call Center at 866-300-4374 | Reaches FDA official within 2 hours (including weekend) |
| Explains how Robert meets criteria over phone | FDA authorizes emergency use verbally |
| Obtains informed consent | Robert (or legal representative) understands risks |
| Begins treatment immediately | Treatment starts same day |
| Notifies IRB within 5 working days | IRB receives emergency use notification |
| Submits Form 3926 within 15 working days | Written documentation follows phone authorization |
Scenario 3: Dr. Patel’s Follow-Up Safety Report
Dr. Patel previously obtained expanded access for patient James. Two weeks into treatment, James experiences an unexpected serious adverse reaction—severe liver enzyme elevation not previously associated with the drug.
| Action Dr. Patel Takes | Resulting Outcome |
|---|---|
| Determines event is serious and unexpected | Clock starts for reporting timeline |
| Completes Form 3926 Field 4.b (follow-up) | Indicates this is submission to existing IND |
| Checks Box 1 in Field 9 | Identifies submission as initial IND safety report |
| Submits within 15 calendar days | Meets regulatory deadline |
| Provides follow-up report when available | Additional details submitted within 15 days of receipt |
| Documents in patient record | Maintains complete treatment records |
Emergency vs. Non-Emergency Expanded Access: Key Differences
Understanding which pathway applies to your patient determines your procedural requirements and timeline.
| Aspect | Emergency Expanded Access | Non-Emergency Expanded Access |
|---|---|---|
| Definition | Treatment must start before written submission is possible | Sufficient time exists for written submission and FDA review |
| Initial authorization | Phone call to FDA Emergency Call Center (866-300-4374) | Written Form 3926 submission |
| FDA response time | Hours (typically same day) | Up to 30 days (usually 4 days average) |
| When treatment may begin | Immediately upon verbal FDA authorization | After FDA notification or 30 days from receipt |
| IRB requirement timing | Notify within 5 working days after treatment | Approval required before treatment begins |
| Written submission deadline | Within 15 working days of FDA authorization | Submitted as initial application |
| Field 10.b applicability | Do NOT check (waiver not applicable) | May check to request IRB chair concurrence |
Common Mistakes to Avoid
Mistake 1: Omitting the Letter of Authorization
Consequence: FDA cannot verify the drug’s safety profile without reference to the manufacturer’s IND. Your application may receive a clinical hold until you provide sufficient product information or contact FDA for alternative documentation guidance.
Mistake 2: Providing Vague Clinical Justification
Consequence: Writing “patient has no other options” without specific details about failed treatments forces FDA to request additional information, delaying authorization. Always list specific prior treatments, dates, and outcomes.
Mistake 3: Checking Field 10.b for Emergency Requests
Consequence: Field 10.b requests IRB chair concurrence before treatment begins—but emergency use permits treatment without prior IRB approval. Checking this box creates confusion about your regulatory pathway and intended timeline.
Mistake 4: Using the Manufacturer’s IND Number Instead of Your Own
Consequence: Form 3926 requires your FDA-assigned IND number for follow-up submissions. Using the manufacturer’s commercial IND number creates tracking problems and may misdirect your submission to the wrong application file.
Mistake 5: Missing Safety Report Deadlines
Consequence: Failing to submit safety reports within 15 calendar days for serious events or 7 days for fatal/life-threatening reactions violates your regulatory obligations as sponsor-investigator. This can result in compliance actions and jeopardize future expanded access requests.
Mistake 6: Incomplete Monitoring Plans
Consequence: Failing to describe how you will monitor for toxicity suggests inadequate patient safeguards. Include specific tests, frequencies, and dose modification criteria.
Do’s and Don’ts for Form 3926 Submissions
Do’s
✅ Do contact the manufacturer first – They must agree to provide the drug before you can proceed. The FDA cannot force companies to participate in expanded access.
✅ Do be specific about prior treatments – Detail what was tried, for how long, and why it failed. This demonstrates the patient truly lacks alternatives.
✅ Do include a realistic treatment plan – Specify doses, schedules, and monitoring. Vague plans raise safety concerns.
✅ Do keep copies of everything submitted – You need records for IRB submissions, patient care documentation, and potential FDA inquiries.
✅ Do establish secure email with FDA – Request secure email setup at [email protected] before submissions containing confidential patient information.
Don’ts
❌ Don’t wait until the patient is in crisis – If you anticipate needing expanded access, begin the manufacturer contact and paperwork process early.
❌ Don’t submit without confirming drug supply – Authorization means nothing if the manufacturer cannot ship the product.
❌ Don’t assume phone authorization is complete – Emergency verbal approval must be followed by written submission within 15 working days.
❌ Don’t forget IRB notification for emergencies – Even when prior approval is not required, you must notify the IRB within 5 working days.
❌ Don’t ignore ongoing responsibilities – As sponsor-investigator, you must submit safety reports, annual reports, and treatment summaries throughout the expanded access period.
IRB Review Requirements Explained
The Institutional Review Board plays a critical role in protecting expanded access patients. Understanding IRB requirements prevents treatment delays and ensures regulatory compliance.
Non-Emergency Expanded Access
Standard FDA regulations require IRB approval at a convened meeting with a majority of members present. However, physicians using Form 3926 can request a waiver by checking Field 10.b. When granted, the IRB chairperson or designated member may provide concurrence instead of full board review.
The IRB reviewer examines:
- Patient’s diagnosis and treatment history
- Why alternatives are unsatisfactory
- Known risks of the investigational product
- Physician qualifications
- Informed consent document adequacy
- For pediatric patients: provisions for assent and parental permission
Emergency Expanded Access
Emergency use is exempt from prior IRB approval under 21 CFR 56.104(c). Treatment may begin immediately upon FDA authorization. The physician must notify the IRB within 5 working days of starting treatment. The IRB then conducts review according to its emergency access procedures.
Finding an IRB
If you do not have access to an institutional IRB, independent IRBs can provide review services. The HHS Office for Human Research Protections maintains a searchable database of registered IRBs organized by state.
Informed Consent Requirements
Expanded access requires informed consent meeting all FDA requirements under 21 CFR Part 50. The consent document must clearly explain:
- The investigational nature of the treatment
- Known and potential risks
- Potential benefits (which may include no benefit)
- Alternative treatments, if any exist
- The voluntary nature of participation
- The patient’s right to withdraw at any time
For emergency situations where the patient cannot provide consent and no legal representative is available, the emergency treatment exemption under 21 CFR 50.23 may apply if specific criteria are documented. Consent should be obtained as soon as feasible even when emergency exemptions apply.
Pros and Cons of Using Form 3926
Pros
Simplified process – Form 3926 consolidates requirements into two pages instead of multiple lengthy forms.
Faster completion – Average completion time of 45 minutes versus several hours for traditional IND submissions.
IRB waiver option – Field 10.b enables IRB chair concurrence instead of full board meetings, saving days or weeks.
High approval rate – FDA authorizes over 99% of expanded access requests.
Emergency flexibility – Permits phone authorization with written follow-up for urgent situations.
Cons
Limited to individual patients – Cannot be used for intermediate populations or treatment INDs serving multiple patients.
Ongoing obligations – Sponsor-investigator responsibilities for safety reporting, annual reports, and record-keeping continue throughout treatment.
Manufacturer dependency – Form 3926 submission is pointless without manufacturer agreement to supply the drug.
No guarantee of efficacy – Investigational drugs may not work and could cause serious harm.
Resource intensive – Managing expanded access alongside regular clinical duties requires significant time commitment.
Key Entities and Their Roles
FDA (Food and Drug Administration)
Reviews expanded access applications and determines if treatment may proceed. The FDA evaluates patient eligibility, risk-benefit balance, and whether access will compromise drug development. The FDA approves over 99% of requests and responds to emergencies around the clock.
Treating Physician (Sponsor-Investigator)
The licensed physician who submits Form 3926 becomes a “sponsor-investigator”—responsible for both sponsor and investigator duties. This includes submitting the IND, obtaining informed consent, ensuring IRB review, administering treatment, and reporting safety data.
Drug Manufacturer/Sponsor
The company developing the investigational drug must agree to provide it for expanded access. They issue the Letter of Authorization permitting FDA to reference their IND. Manufacturers set their own expanded access policies, which must be publicly available under the 21st Century Cures Act.
Institutional Review Board (IRB)
Reviews expanded access protocols to protect patient rights and welfare. The IRB assesses whether risks are minimized, benefits justify risks, and informed consent is adequate. For individual patient expanded access, IRB chair concurrence may substitute for full board review upon FDA approval of waiver request.
Patient
The individual receiving treatment. Patients cannot submit expanded access requests themselves but participate by providing informed consent and undergoing treatment monitoring.
How to Submit Form 3926
Submission Methods
You may submit Form 3926 by:
- Secure email – Recommended method; request setup at [email protected]
- Fax – To the appropriate FDA review division
- Mail – Physical submission to FDA offices
Contact information for specific review divisions is available on FDA’s Expanded Access Contact Information page.
What to Include
A typical application package contains:
- Completed Form FDA 3926
- Letter of Authorization from manufacturer (if applicable)
- First few pages of physician’s CV (or qualification statement in Field 8)
- Any supporting documents (Investigator’s Brochure, publications)
After Submission
FDA assigns an IND number and reviews your application. For non-emergency requests, treatment may begin after FDA notification or 30 days from receipt, whichever comes first. If FDA identifies concerns, they will contact you—usually by phone—before placing a clinical hold.
FAQs
Can patients apply for expanded access themselves?
No. Only a licensed physician overseeing the patient’s care may submit expanded access requests. Patients should discuss expanded access options with their doctor.
Does the FDA ever deny expanded access requests?
Yes, but rarely. FDA authorizes over 99% of requests. Denials typically occur when patient eligibility criteria are not met or risk outweighs potential benefit.
How long does FDA take to respond to Form 3926?
Usually 4 days for non-emergency requests. Emergency requests often receive phone authorization within hours. FDA has 30 days maximum for written submissions.
Can I use Form 3926 for multiple patients?
No. Form 3926 applies only to individual patients. Intermediate-size populations require Forms 1571 and 1572 submitted to a separate expanded access protocol.
What if the manufacturer won’t provide a Letter of Authorization?
Contact the FDA review division directly. They can advise what alternative information you must provide about the drug’s chemistry, manufacturing, and safety profile.
Do I need IRB approval before starting emergency treatment?
No. Emergency expanded access is exempt from prior IRB approval. However, you must notify the IRB within 5 working days after treatment begins.
What happens if my patient experiences a serious adverse event?
Report within 15 calendar days (or 7 days if fatal/life-threatening) using Form 3926 as a follow-up submission. Check the appropriate box in Field 9.
Can I charge the patient for the investigational drug?
Sometimes. FDA permits cost recovery in specific circumstances under 21 CFR 312.8. Contact FDA and review the charging regulations before billing patients.
How long are sponsor-investigator responsibilities?
Until treatment ends and FDA is notified. You must submit annual reports, safety reports, and a final treatment summary. Responsibilities cease after FDA acknowledges your withdrawal notification.
Does expanded access affect future drug approval?
Rarely negatively. FDA reviewers understand the context of expanded access—seriously ill patients who may experience adverse events unrelated to the drug. Adverse events from expanded access have not prevented FDA approvals.