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  5. Transcript: Expanded Access Part 3: How to Complete Form FDA 3926 for Initial Submissions
  1. Information for Healthcare Professionals (Drugs)

Transcript: Expanded Access Part 3: How to Complete Form FDA 3926 for Initial Submissions

Form FDA 3926 is a one-page form, front and back. Detailed instructions are available on the FDA website. Form FDA 3926 covers both initial and follow-up expanded access submissions for investigational drugs, including biologics.

Form FDA 3926 contains 11 fields.

In field 1, enter the patient’s initials. The patient does not need to initial the form.

In field 2, provide the date of submission, and check either 3.a. or 3.b., depending on if this is a new expanded access request or if you are submitting a follow-up to add information to an existing request. For follow-up submissions to an existing request, enter the IND number assigned to the application by FDA.

Fields 4 through 7 are completed only for initial requests.

In field 4, enter clinical information including the indication for use and a brief clinical history of the patient. Include the patient’s age, gender, weight, allergies, diagnosis, prior therapy, response to prior therapy, and the reason for the request, including an explanation of why the patient lacks other therapeutic options.

In field 5, provide treatment information, including the name of the investigational drug and the name of the company supplying the drug. The treatment plan should include the dose, route, and schedule of administration; planned duration of treatment; and monitoring procedures that will be used. Include any anticipated modifications to the treatment plan in the event the patient experiences toxicity.

Field 6 should be completed if you are attaching a Letter of Authorization. If the company isn’t providing a letter, contact the FDA Review Division for advice on what other sources of information may satisfy the submission requirements for your IND.

In field 7, provide your qualifications as a physician, including the name of the medical school attended, year of graduation, medical specialty, state medical license number, current employment, and job title. As an alternative, the first few pages of your CV will suffice if that contains the required information.

In field 8, enter your contact information. This field should always be completed for initial and follow-up submissions.

Field 9 is only for follow-up submissions. Part 4 of this series is a detailed description of required follow-up submissions.

Field 10 has two check boxes. Field 10.a. is the request for authorization to use Form FDA 3926 to meet all of the IND requirements. Field 10.b. is the box to check if you are requesting to use alternative IRB review procedures. These procedures allow concurrence from the IRB chairperson or another designated member prior to treatment in lieu of full IRB review.

Field 11 is the certification statement. By signing below field 11, you are agreeing not to begin treatment with the investigational drug until notified by FDA or until 30 days after FDA receives the application. You also agree not to begin or continue treatment if the application is placed on clinical hold. This field also provides certification that you agree to obtain informed consent from the patient, obtain IRB review and approval, and fulfill all applicable regulatory requirements.

A typical application consists of these 3 documents:

  1. a completed Form FDA 3926,
  2. a Letter of Authorization from the entity supplying the drug, and
  3. the first few pages of your CV.

Send the application via secure e-mail, fax, or mail. FDA addresses and contact information are available on our website.

It’s that easy!

For assistance, contact FDA’s Division of Drug Information. If you’re already working with the Review Division, give them a call.

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