If a pharmaceutical company agrees to supply the investigational treatment, the treating physician must next request permission to proceed from the FDA through a form FDA 3926, also known as the Individual Patient Expanded Access Investigational New Drug Application.

For a detailed explanation of how to fill out Form FDA 3926, click here and see related industry guidance for the form.

NOTE: Internet Explorer is needed to access the most up-to-date form directly from FDA’s website. Accessing the form directly from FDA on Internet Explorer allows you to electronically fill out the information required, before saving to fax, email as an attachment or mail to FDA.

Alternatively, to view or download a sample of FDA FORM 3926 click on the download button below. Please note this method of accessing the form does not facilitate electronically typing in the fields.

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