Individual Patient Expanded Access Applications: Form FDA 3926; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled "Individual Patient Expanded Access Applications: Form FDA 3926." The draft guidance provides for public comment and describes draft Form FDA 3926 (Individual Patient Expanded Access--Investigational New Drug Application (IND)), which, when finalized, FDA intends to make available for licensed physicians to use for expanded access requests for individual patient INDs. Individual patient expanded access allows for the use of an investigational drug outside of a clinical trial for an individual patient who has a serious or immediately life-threatening disease or condition and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition. When finalized, draft Form FDA 3926 is intended to provide a streamlined alternative for submitting an Investigational New Drug Application (IND) for use in cases of individual patient expanded access.