FDA 3926 Individual Patient Expanded Access Investigational New D

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Individual Patient Expanded Access
Investigational New Drug Application (IND)

Form Approved: OMB No. 0910-0814
Expiration Date: June 30, 2025
See PRA Statement on last page.

(Title 21, Code of Federal Regulations (CFR) Part 312)
1. Physician Name, Name of Institution or Clinical Practice, Address, and Contact Information
Email Address of Physician
Physician Name (Sponsor)
Name of Institution or Clinical Practice
Address 1 (Street address, No P.O. boxes)
Telephone Number of Physician

Address 2 (Apartment, suite, unit, building, floor, etc.)
City

State

Facsimile (FAX) Number of Physician

ZIP Code

2. Patient’s Initials

3. Date of Submission (mm/dd/yyyy)

4. Type of Submission
NOTE: Checking box 4a or 4b will “turn on” ONLY the fields that must be completed.
4.a. Initial Submission
4.b. Follow-Up Submission

Investigational Drug Name

Select this box if this form is an
initial submission for an individual
patient expanded access IND,
enter the Physician's IND Number,
if previously issued by FDA, and
complete only fields 5 through 8,
and fields 10 and 11.
5. Clinical Information
Indication

Physician’s IND Number (if known)

Select this box if this form accompanies
a follow-up submission to an existing
individual patient expanded access IND,
and complete the items to the right in this
section, and fields 9 through 11.

Brief Clinical History (Patient’s age, gender, weight, allergies or sensitivities, race and ethnicity (optional), diagnosis, prior therapy,
response to prior therapy, reason for request, including an explanation of why the patient lacks other therapeutic options)

Ethnicity (check one)
Hispanic/Latino
Not Hispanic/Latino

FORM FDA 3926 (08/22)

Race (check all that apply)
American Indian/Alaska Native
Black or African American
Native Hawaiian/Other Pacific Islander

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Asian
White

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6. Treatment Information
Investigational Drug Name
Name of the entity that will supply the drug (generally the manufacturer)
FDA Review Division (if known)

Treatment Plan (Including the dose, route and schedule of administration, planned duration, and monitoring procedures. Also include
modifications to the treatment plan in the event of toxicity.)

7. Letter of Authorization (LOA), if applicable (generally obtained from the manufacturer of the drug)
I have attached the LOA. (Attach the LOA; if electronic, use normal PDF functions for file attachments.)
Note: If there is no LOA, consult the Form Instructions.

8. Physician’s Qualification Statement (Including medical school attended, year of graduation, medical specialty, state medical
license number, current employment, and job title. Alternatively, attach the first few pages of physician’s curriculum vitae (CV),
provided they contain this information. If attaching the CV electronically, use normal PDF functions for file attachments.)

9. Contents of Submission
This submission contains the following materials, which are attached to this form (select all that apply). If none of the following apply to the
follow-up communications, use Form FDA 1571 for your submission.
Initial Written IND Safety Report

Change in Treatment Plan

Follow-up to a Written IND Safety Report

General Correspondence

Annual Report

Response to FDA Request for Information

Summary of Expanded Access Use (treatment completed)

Response to Clinical Hold

Request for Withdrawal

10.a. Request for Authorization to Use Form FDA 3926
I request authorization to submit this Form FDA 3926 to comply with FDA’s requirements for an individual patient expanded access IND.

10.b. Request for Authorization to Use Alternative IRB Review Procedures
I request authorization to obtain concurrence by the Institutional Review Board (IRB) chairperson or by a designated IRB member, before
the treatment use begins, in order to comply with FDA's requirements for IRB review and approval. This concurrence would be in lieu of
review and approval at a convened IRB meeting at which a majority of the members are present.

FORM FDA 3926 (08/22)

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11. Certification Statement: I will not begin treatment until 30 days after FDA’s receipt of a completed application and all

required materials unless I receive earlier notification from FDA that treatment may begin. I also agree not to begin or
continue clinical investigations covered by the IND if those studies are placed on clinical hold. I also certify that I will obtain
informed consent, and that an Institutional Review Board (IRB) will be responsible for initial and continuing review and
approval of this treatment use, consistent with applicable FDA requirements. I understand that in the case of an emergency
request, treatment may begin without prior IRB approval, provided the IRB is notified of the emergency treatment within 5
working days of treatment. I agree to conduct the investigation in accordance with all other applicable regulatory requirements.

WARNING: A willfully false statement is a criminal offense (U.S.C. Title 18, Sec. 1001).
Signature of Physician

Date

To enable the signature field, please fill out all prior required fields. For a list of required fields
which have not yet been filled out, please click here.

Information on where and how to submit this form is available at Expanded Access – How to Submit

For FDA Use Only
Date of FDA Receipt

Is this an emergency individual patient IND?
Yes

IND Number

Is this indication for a rare disease (prevalence
< 200,000 in the U.S.)?

No

Yes

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FORM FDA 3926 (08/22)

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No