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Guidance Issuing OfficeCenter for Drug 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2015-D-0268.