FORM FDA 3613

Instructions and help about FORM FDA 3613

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 4-7 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 explanati