This guidance describes Form FDA 3926 (Individual Patient Expanded Access – Investigational New Drug Application (IND)), which is available for licensed physicians to use for expanded access requests for individual patient INDs. The terms compassionate use and preapproval access are also occasionally used in the context of the use of an investigational drug to treat a patient; however, these terms are not defined or described in FDA regulations. Individual patient expanded access allows for the use of an investigational new drug3 outside of a clinical investigation, or the use of an approved drug where availability is limited by a risk evaluation and mitigation strategy (REMS), for an individual patient who has a serious or immediately lifethreatening disease or condition and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition. Form FDA 3926 provides a streamlined alternative for submitting an IND under 21 CFR 312.23 for use in cases of individual patient expanded access, including for emergency use. This guidance and Form FDA 3926 do not apply to other types of expanded access requests, including requests for expanded access for medical devices.