(CDER) Submissions related to expanded access and treatment of an individual patient

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.)
Do not attempt to fill out this form after opening in your Internet Browser. To enable field fillable functionality,
first save the file to your local computer, close the file and re-open the Form. Checking either box 3a
or 3b will enable the appropriate fields to be fillable. Form should be completed electronically, i.e., not
hand-written.
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
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FORM FDA 3926 SUPPLEMENT (11/20) – INSTRUCTIONS
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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.
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))
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Field 10.a: REQUEST FOR AUTHORIZATION TO USE FORM FDA 3926 FOR INDIVIDUAL PATIENT
EXPANDED ACCESS
Select this box to request under 21 CFR 312.10, that FDA accept the completed Form FDA 3926 to satisfy
FDA’s requirements for submitting an individual patient expanded access IND.
Field 10.b: REQUEST FOR AUTHORIZATION TO USE ALTERNATIVE IRB REVIEW PROCEDURES
Select this box to request under 21 CFR 56.105, authorization to obtain concurrence by the IRB chairperson
or by a designated IRB member, instead of at a convened IRB meeting, before the treatment use begins, in
order to comply with FDA’s requirements for IRB review and approval.
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 FDA requirements (see 21 CFR part 50) and that an Institutional Review Board (IRB)will
be responsible for initial and continuing review and approval of the expanded access use, consistent with
applicable FDA requirements (see 21 CFR part 56). 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 (11/20) – INSTRUCTIONS
(PREVIOUS EDITIONS OBSOLETE)

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