Individual Patient Expanded Access Applications: Form FDA 3926 | Guideline Explorer

Description

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 termscompassionate useandpreapproval accessare 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 drug3outside 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.

Scope & Applicability

Product Classes

2

biological products

Regulated by CDER and CBER

investigational drug

The drug being tested in clinical trials for MDS.

Stakeholders

3

Sponsor-investigator

Individual who both initiates and conducts an investigation.

IRB chairperson

Position title used to identify who carries out specific duties

physician

medical professional requesting HCT/P for urgent need; requesting HCT/P based on urgent medical need

Related CFR Sections (6)

21CFR56.104§ 56.104 Exemptions from IRB requirement.
The following categories of clinical investigations are exempt from the requirements of this part for IRB review:Read full regulation →
21CFR312.310§ 312.310 Individual patients, including for emergency use.
Under this section, FDA may permit an investigational drug to be used for the treatment of an individual patient by a licensed physician.Read full regulation →
21CFR312.305§ 312.305 Requirements for all expanded access uses.
The criteria, submission requirements, safeguards, and beginning treatment information set out in this section apply to all expanded access uses described in this subpart. Additional criteria, submission requirements, and safeguards that apply to specific types of expanded access are described in §§Read full regulation →
21CFR312.320§ 312.320 Treatment IND or treatment protocol.
Under this section, FDA may permit an investigational drug to be used for widespread treatment use.Read full regulation →
21CFR312.315§ 312.315 Intermediate-size patient populations.
Under this section, FDA may permit an investigational drug to be used for the treatment of a patient population smaller than that typical of a treatment IND or treatment protocol. FDA may ask a sponsor to consolidate expanded access under this section when the agency has received a significant numbeRead full regulation →
21CFR312.23§ 312.23 IND content and format.
(a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:Read full regulation →

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