Form FDA 3926 is the Individual Patient Expanded Access – Investigational New Drug Application (IND), which is used by physicians to request expanded access for individual patients.

FDA revised its IND regulations in 2009 by removing the existing regulations on treatment use and creating subpart I of 21 CFR part 312 to consolidate and expand the various provisions regarding expanded access to treatment use of investigational drugs.¹

These regulations were intended to facilitate the availability of investigational new drugs for treatment use while protecting patient safety.

The FDA can permit expanded access to an investigational new drug outside of a clinical investigation, or to an approved drug where availability is limited by a risk evaluation and mitigation strategy (REMS).¹ There are three requirements that the FDA must determine apply to the respective IND:

1. The patient to be treated 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;

2. The potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated; and

3. Providing the investigational drug for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.¹

Further, the physician must also determine that the probable risk to the person from the investigational product is not greater than the probable risk from the disease or condition. Also, the FDA must determine that the patient cannot obtain the drug under another IND or protocol.¹

An individual patient IND using form 3926 is either submitted prospectively or retrospectively, a retrospective submission is accepted in emergency situations.² A physician will follow this process for a non-emergency individual patient IND:

1. Request a Letter of Authorization (LOA)

2. Submit Form FDA 3926

3. Obtain Institutional Review Board (IRB) approval

4. Obtain Informed Consent

5. Begin Treatment 30 days after application is received by FDA (or earlier if notified by FDA)

6. File Follow-up Report(s)²

The LOA permits FDA to refer to information that the sponsor of the IND has submitted to FDA, if an LOA cannot be obtained, the physician should contact the relevant review division at the FDA to determine what information is necessary to support the submission.¹ Follow-up reports include: safety reports, protocol or information amendments, summary upon treatment completion and annual reports.² 

In an emergency situation that requires the patient to be treated before a written submission can be made, the request to use the investigational drug for individual patient expanded access may be made by telephone (or other rapid means of communication) to the appropriate FDA review division. Authorization of the emergency use may be given by an FDA official by telephone, if a physician explains how the expanded access use will meet the aforementioned requirements and agrees to submit an expanded access application within fifteen business days of FDA’s initial authorization. An IRB should also be notified within five business days of treatment initiation.²

In 2020, the FDA received a total of 6954 INDs for commercial, research, and emergency use.³ On average, FDA determines that 99% of all expanded access requests may proceed.²

Expanded access requests for medical devices do not require use of an official FDA form.²

1. Individual Patient Expanded Access Applications: Form FDA 3926. Silver Spring, MD: US Food and Drug Administration; 2017. https://www.fda.gov/media/91160/download.

2. Expanded Access: How to Submit a Request (Forms). U.S. Food and Drug Administration. https://www.fda.gov/news-events/expanded-access/expanded-access-how-submit-request-forms#PhysicianNonEmergency-sbs. Published 2019. 

3. About FDA. Accessdata.fda.gov. https://www.accessdata.fda.gov/scripts/fdatrack/view/track.cfm?program=cber&status=public&id=CBER-All-IND-and-IDEs-recieved-and-actions&fy=All. Published 2021.