Expanded Access Submission for Treatment of an Individual Patient, Including Submission of Form FDA 3926

INSTRUCTIONS FOR FILLING OUT FORM FDA 3926 – INDIVIDUAL PATIENT EXPANDED
ACCESS, INVESTIGATIONAL NEW DRUG APPLICATION (IND)
(The field numbers below correspond to the numbered boxes on the Form FDA 3926.)
Field 1: PATIENT’S INITIALS
Enter the patient’s initials (not the full name, to preserve confidentiality). The patient need not initial the form.
Field 2: DATE OF SUBMISSION
Provide the date of the submission in the following format: mm/dd/yyyy.
Field 3: TYPE OF SUBMISSION
(3.a.) Initial Submission: If the submission is an initial (original) submission for an individual patient
expanded access IND (including for emergency use), select the box provided in field 3.a. and complete
only fields 4 through 8, and fields 10 and 11.
(3.b.) Follow-Up Submission: If this is a follow-up submission to an existing individual patient expanded
access IND, select the box provided in field 3.b. and complete the items to the right of the checkbox in
field 3.b. (Investigational Drug Name and the physician’s existing IND Number), and fields 8 through 11.
Do not include the commercial sponsor’s IND number.
Field 4: CLINICAL INFORMATION
Provide the indication (proposed treatment use) and a brief clinical history of the patient. The clinical history
includes age, gender, weight, allergies, diagnosis, prior therapy, response to prior therapy, and the reason for
requesting the proposed treatment, including an explanation of why the patient lacks other therapeutic options.
Field 5: TREATMENT INFORMATION
Provide treatment information, including the investigational drug’s name and the name of the entity supplying
the drug (generally the manufacturer), the applicable FDA review division (if known), and a concise statement
regarding the treatment plan. This includes the planned dose, route and schedule of administration, planned
duration of treatment, monitoring procedures, and planned modifications to the treatment plan in the event of
toxicity. The information should be entered within the space provided.
Field 6: LETTER OF AUTHORIZATION (LOA), IF APPLICABLE
An LOA grants FDA the right to reference another application (IND) for information to satisfy submission
requirements, such as a description of the manufacturing facility, chemistry, manufacturing and controls
information, and pharmacology and toxicology information.
How to obtain an LOA: The physician is responsible for obtaining the LOA in advance from the entity
that is the sponsor of the IND (e.g., commercial sponsor/drug manufacturer) being referenced. Physicians
should attach the LOA to Form FDA 3926. The LOA should include the IND number for the application
being referenced.
If the LOA is unavailable: In cases where it is not possible to obtain an LOA (e.g., the entity
supplying the drug does not have an IND already filed with FDA), physicians should contact the
the applicable FDA review division (see http://www.fda.gov/NewsEvents/PublicHealthFocus/
ExpandedAccessCompassionateUse/ucm429610.htm) to determine what other sources of information
may satisfy the regulatory requirements.
For emergency individual patient expanded access INDs, the physician must submit the LOA (if applicable)
and all other paperwork (including Form FDA 3926) to FDA within 15 working days of FDA’s initial
authorization.
FORM FDA 3926 SUPPLEMENT (3/16) – FORM INSTRUCTIONS

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Field 7: PHYSICIAN’S QUALIFICATION STATEMENT
Provide a statement of the physician’s qualifications. An appropriate qualification statement includes the
medical school attended, year of graduation, medical specialty, state medical license number, current
employment, and job title. Alternatively, the relevant portion of the physician’s curriculum vitae that includes
this information (usually the first few pages) may be attached.
Field 8: PHYSICIAN’S NAME, ADDRESS, AND CONTACT INFORMATION
Enter the physician’s name and contact information, including the physical address, email address, telephone
number, facsimile (FAX) number, and physician’s IND number, if previously issued by the FDA. Do not include
the commercial sponsor’s IND number here.
Field 9: CONTENTS OF SUBMISSION (FOLLOW-UP/ADDITIONAL SUBMISSIONS ONLY)
This field should only be completed for follow-up/additional submissions to an existing individual patient
expanded access IND. Select the appropriate box (or boxes, if more than one apply) and attach the materials
indicated for the following categories of follow-up/additional submissions (the relevant FDA regulations are
provided in parentheses for additional details).
If none of the following apply to the follow-up/additional communications, use Form FDA 1571 for your
submission.
• Initial Written IND Safety Report: A report of potential serious risks to be submitted as soon as possible
but no later than 15 calendar days after the sponsor (i.e., the physician, who is considered a sponsorinvestigator) determines that information qualifies for reporting, or, a report of unexpected fatal or lifethreatening suspected adverse reactions, submitted no later than 7 calendar days after the sponsor’s
initial receipt of the information (21 CFR 312.32(c))
• Follow-up to a Written Safety Report: A follow-up report to an IND safety report, to be made as soon
as the information is available but no later than 15 calendar days after the sponsor receives the
information (21 CFR 312.32(d))
• Annual Report: A brief report of the progress of the investigation, submitted within 60 days of the
anniversary date that the IND went into effect (21 CFR 312.33)
• Summary of Expanded Access Use (treatment completed): A written summary of the results of the
expanded access use, including adverse effects, at the conclusion of treatment (21 CFR 312.310(c)(2))
• Change in Treatment Plan: Also known as protocol amendments; a submission describing changes in
the IND, including changes of investigators (21 CFR 312.30)
• General Correspondence: Any other communication between the sponsor and FDA pertinent to the
investigation (21 CFR 312.41)
• Response to FDA Request for Information: A submission containing responses to clinical information
requests (21 CFR 312.41)
• Response to Clinical Hold: A submission correcting deficiencies previously cited in a FDA Clinical Hold
letter (21 CFR 312.42(e))
Field 10: REQUEST FOR AUTHORIZATION TO USE FORM FDA 3926 FOR INDIVIDUAL PATIENT
EXPANDED ACCESS
Select this box to request that FDA accept the completed Form FDA 3926 to satisfy FDA’s requirements for
submitting an individual patient expanded access IND.
Generally, an IND submission for purposes other than individual patient expanded access includes additional
information, beyond that included in Form FDA 3926. Therefore, consistent with 21 CFR 312.10, FDA intends
to consider a completed Form FDA 3926 with the box in Field 10 checked, to be a request for a waiver of any
additional requirements in 21 CFR part 312 for an IND submission.

FORM FDA 3926 SUPPLEMENT (3/16) – FORM INSTRUCTIONS

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Field 11: CERTIFICATION STATEMENT AND SIGNATURE OF THE PHYSICIAN
The licensed physician identified in Field 8 must sign this field. By signing this field, the physician certifies that
treatment will not begin until 30 days after FDA receives the completed application and all required materials
unless the submitting physician receives earlier notification from FDA that the treatment may proceed. The
physician agrees not to begin or continue clinical investigations covered by the IND if those studies are placed
on clinical hold. The physician also certifies that informed consent will be obtained in compliance with Federal
requirements (including FDA’s regulations in 21 CFR part 50) and that an Institutional Review Board (IRB)
that complies with all Federal requirements (including FDA’s regulations in 21 CFR part 56) will be responsible
for initial and continuing review and approval of the expanded access use. The physician also acknowledges
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. The physician agrees to conduct the
investigation in accordance with all other applicable regulatory requirements.

FORM FDA 3926 SUPPLEMENT (3/16) – FORM INSTRUCTIONS

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