Request a Letter of Authorization (LOA) from the pharmaceutical company that makes the investigational drug you wish to obtain. A LOA grants the right of reference to the information contained in the supplier’s existing Investigational New Drug (IND) application. If a LOA is not available, submit sufficient information for FDA to assure the product’s quality. A Letter of Authorization template is available from FDA.
Submit Form FDA 3926
Instructions for filling out Form FDA 3926 are available online.
Submit Form FDA 3926 (along with the LOA) to FDA. You may submit via mail, fax, or e-mail. Further instructions and help about how to submit available online.
Obtain IRB approval
Obtain IRB approval per 21 CFR Part 56. A physician submitting an individual patient expanded access IND using Form FDA 3926 may choose to request authorization to obtain concurrence by the IRB chairperson or by a designated IRB member before the treatment use begins, in lieu of obtaining IRB review and approval at a convened IRB meeting at which a majority of the members are present. A physician submitting an individual patient expanded access IND using Form FDA 1571 may include a separate waiver request with the application.
Obtain Informed Consent
Obtain Informed Consent from patient or their legally authorized representative per 21 CFR Part 50.