Expanded Access to Investigational Drugs for Treatment Use

This ICR collects information from licensed physicians who submit requests for expanded access to investigational drugs on behalf of individual patients. Physicians may use Form FDA 3926 instead of Form FDA 1571 for the submission of information as described in the regulations (e.g., the rationale for the intended use of the drug and the physician’s qualifications). We use the information to determine whether the access request can be granted. Form FDA 3926 may also be used for certain follow-up submissions to existing individual patient expanded access INDs as described in FDA regulations (e.g., to submit an annual report or summary of expanded access use (treatment completed)).

The latest form for Expanded Access to Investigational Drugs for Treatment Use expires 2022-05-31 and can be found here.