Form FDA 3926 Rev 2017

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Individual Patient Expanded Access Investigational New Drug Application (IND) (Title 21, Code of Federal Regulations (CFR) Partt 312)	Form Approved: OMB No. 0910-0814 Expiration Date: April 30, 2019 See PRA Statement on last page.
	I

1. Patient's Initials		2. Date of Submission (mmlddlyyyy)
3.a. Initial Submission D Select this box if this form is an initial submission for an individual patient expanded access IND, and complete only fields 4 through 8, and fields 10 and 11.	3.b. Follow-Up Submission D 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 8 through 11.	Investigational Drug Name
		Physician's IND Number

4. Clm1callnformat1on

Indication

Brief Clinical History (Patient's age, gender, weight, allergies, diagnosis, prior therapy, response to prior therapy, reason for request, including an explanation of why the patient lacks other therapeutic options)

5. 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.)

6. Letter of Authorization (LOA), if applicable (generally obtained from the manufacturer of the drug)

D 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.

7. 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.)

8. Physician Name, Address, and Contact Information

Physician Name (Sponsor) Email Address of Physician

Address 1 (Street address, No P.O. boxes)

_{Address 2 (Apartment, suite, unit, building, floor, etc.) Telephone Number of Physician}

City

_{I state}

Facsimile (FAX) Number of Physician

ZIP Code Physician's IND number, if known

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.

D Initial Written IND Safety Report

0 Follow-up to a Written IND Safety Report

0 Annual Report

_{0 Summary of Expanded Access Use (treatment completed)}

0 Change in Treatment Plan

0 General Correspondence

D Response to FDA Request for Information

_{0 Response to Clinical Hold}

10.a. Request for Authorization to Use Form FDA 3926

0 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

0 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.

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, consistent with Federal requirements, and that an Institutional Review Board (IRB) that complies with the Federal IRB requirements 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

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.

Date

_{For FDA Use Only}

Date of FDA Receipt	Is this an emergency individual patient INO? 0 Yes 0 No	Is this indication for a rare disease (prevalence < 200,000 in the U.S.)? 0 Yes 0 No
IND Number

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FORM FDA 3926 (2116)

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