Individual Patient Expanded Access Applications: Form FDA 3926 October 2017

GUIDANCE DOCUMENT

• Docket Number: FDA-2015-D-0268
• Issued by: Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research

This guidance describes From FDA 3926² (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 occasional 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 sue 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 life-threatening disease or condition and there is no comparable or satisfactory alternative therapy for submitting an IND under 21 312.23 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 request for expanded access for medical devices.

OMB Control Number:  0910-0814

Expiration Date:  06/30/2025

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