FDA Form 3926

FDA Form 3926 (“Individual Patient Expanded Access Investigational New Drug Application”) is the streamlined application a treating physician files with the U.S. Food and Drug Administration to request expanded access (“compassionate use”) to an investigational drug — or an approved drug whose distribution is restricted by a Risk Evaluation and Mitigation Strategy (REMS) — for a single, named patient outside of a clinical trial. It sits inside the individual-patient category of FDA’s expanded access framework, codified at 21 CFR Part 312, Subpart I, and is the form most physicians use for that category rather than filing a full commercial Investigational New Drug (IND) application on Form FDA 1571.

What counts as a Form 3926 request

A request qualifies as a Form-3926-based individual-patient expanded access application when all of the following hold:

• The treating physician (not the manufacturer) submits the request, addressed to the FDA review division responsible for the product (CDER or CBER).
• The drug’s manufacturer/sponsor has agreed, generally via a Letter of Authorization (LOA), to supply the product for this specific patient.
• The physician has documented the patient’s brief clinical history — diagnosis, prior therapy and response, and why no comparable or satisfactory alternative therapy exists — along with a treatment plan covering dose, route, schedule, duration, and monitoring, including how toxicity would be managed.
• FDA has not objected within the applicable waiting period, or has affirmatively authorized the request.

FDA describes Form 3926 as purpose-built to be easier for a treating physician to complete than the alternative of filing a full IND application — it consolidates the clinical-history, treatment-plan, and authorization information a single-patient request needs into one physician-facing form, rather than requiring the fuller structure of a commercial or research IND.

Individual patient vs. the other expanded access categories

FDA organizes expanded access into three categories, and Form 3926 belongs to only one of them:

• Individual patient (including emergency use) — the Form 3926 category. Covers one named patient. In a genuine emergency, where there is no time for the standard written submission, FDA can authorize treatment by telephone or other rapid means before the paperwork is complete; the physician then completes and files Form 3926 (and other required documentation) afterward.
• Intermediate-size patient population — a defined group larger than one patient, typically sharing the same disease with no other access pathway (common for rare diseases). This is not a Form 3926 submission.
• Treatment IND / treatment protocol — widespread access to a promising drug in later development, generally sponsor-initiated. Also not a Form 3926 submission.

See Compassionate Use and Expanded Access: FDA Pathways Explained for how all three categories, and the general eligibility criteria that apply across them, fit together.

Submission and timeline

Once FDA receives a complete Form 3926 application, the investigational drug may be shipped and treatment may begin 30 days after receipt, or sooner if FDA notifies the physician that treatment may proceed — whichever comes first. Concurrent requirements outside the form itself still apply: institutional review board (IRB) concurrence (which can be obtained through an abbreviated single-patient IRB review process at many institutions), documented informed consent from the patient or their legally authorized representative, and safety reporting obligations to FDA and the sponsor once treatment begins. FDA has reported that it allows the large majority of individual patient expanded access requests to proceed.

Form 3926 vs. the Right to Try Act

Form 3926 requests go through FDA. The Right to Try Act (2018) created a separate, parallel pathway that does not: an eligible patient may request an eligible investigational drug directly from the manufacturer without an FDA authorization request for that use, though the manufacturer’s participation remains voluntary under either pathway. A physician choosing between the two routes is choosing between different eligibility criteria and different points of federal involvement, not different versions of the same form.

Worked examples

Example 1 — standard individual-patient request. A physician is treating a patient with a rare, rapidly progressing disease for whom no approved therapy remains and who does not qualify for an ongoing trial of a relevant investigational drug (for instance, the trial’s eligibility criteria exclude the patient’s disease stage). The physician contacts the drug’s sponsor, obtains a Letter of Authorization, documents the clinical history and treatment plan, and files FDA Form 3926 requesting individual-patient expanded access.

Example 2 — emergency use. A physician faces a genuinely life-threatening situation with no time to complete the standard written submission. The physician contacts FDA’s emergency line by phone; FDA authorizes emergency treatment verbally, and the physician submits Form 3926 and the remaining required documentation afterward.

Counter-examples

Not a Form 3926 case: A request covering multiple patients who share the same diagnosis (for example, 15 patients with the same rare disease) falls under the intermediate-size patient population category, not individual-patient expanded access — it does not use Form 3926.

Not a Form 3926 case: A sponsor seeking to make an investigational drug broadly available to many patients while continuing to gather data supporting eventual approval is pursuing a treatment IND or treatment protocol, a sponsor-initiated pathway distinct from the physician-initiated, single-patient Form 3926 process.

Not a Form 3926 case: A patient obtaining an investigational drug directly from the manufacturer under the Right to Try Act, without any request to FDA, never involves Form 3926 — Right to Try operates entirely outside the expanded access pathway that the form belongs to.