Single Patient IND: how it works and where it is recognized

Last reviewed 2026-05-16 by Reserve Meds clinical and regulatory team.

What Single Patient IND is

Origin and authorising body. United States Food and Drug Administration, 21 CFR 312.310 (individual patient expanded access). The authorising body for each individual case is the United States Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER), with parallel destination-country regulator review for cross-border supply, acting under that jurisdiction's pharmacy or medicines legislation.

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Legal basis. 21 CFR 312.310 establishes the framework for individual patient expanded access (a Single Patient IND). The treating physician (or, where the manufacturer agrees, the manufacturer) submits an application on Form FDA 3926 documenting the patient's serious or life-threatening condition, the absence of satisfactory alternatives, and the rationale for the investigational drug. The FDA has 30 calendar days to object, after which treatment may proceed.

A Single Patient IND is the most common form of FDA Expanded Access. It authorises the supply of an investigational drug to one named patient under one treating physician for a defined treatment course. The Single Patient IND framework is distinct from a routine clinical-trial IND in several ways: it is not designed to generate registration data, it does not require a formal trial protocol with multiple subjects, and it is granted on a case-by-case clinical-need basis rather than through a research-design lens. The treating physician acts as sponsor-investigator (or the manufacturer acts as sponsor and the physician is the investigator). For cross-border patients, the Single Patient IND on the US side pairs with a destination-country named-patient or compassionate-use permit on the receiving side.

Form FDA 3926 was introduced specifically to simplify the individual patient expanded-access application. It folds the IND application, informed consent template, and IRB notification into one document. The form is designed so that a treating physician without prior IND filing experience can complete it. For emergency cases, the FDA permits initial authorisation by phone or fax during business hours and after hours, with written submission via Form FDA 3926 following within 15 working days. The IRB requirement can be satisfied by concurrent IRB review for emergency cases.

This page consolidates Reserve Meds's operational view of the Single Patient IND framework across the ten destination countries where we currently coordinate cross-border supply. Earlier in our content build we maintained separate per-country sub-pages for each Single Patient IND-in-country combination; those sub-pages remain available for archival reference but are no longer separately indexed, and the operational intelligence they carried has been folded into the country-compatibility table below.

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Who can use Single Patient IND

Single Patient IND is used by US-licensed physicians on behalf of patients with serious or life-threatening conditions for whom no satisfactory alternative therapy is available. International physicians cannot directly hold a US IND, but the US manufacturer can supply under a Single Patient IND held by a US physician collaborator, with the receiving-country physician handling clinical management on the destination side. For cross-border supply, the operational workflow is: destination physician identifies the clinical need, US-side coordinator engages the manufacturer and arranges a US-based collaborator physician or sponsor-investigator structure, FDA Single Patient IND is filed and cleared, destination-country named-patient permit is filed in parallel, supply is released once both clearances are in place.

In practical terms, a Reserve Meds case opens when the treating physician has identified the clinical need, has reached a decision to prescribe a specific medicine, and has determined that the locally available route is unsuitable or unavailable. We then layer the regulatory and supply-chain coordination on top of that clinical decision; we do not originate the prescribing question and we do not advise on the clinical choice. The decision sits with the physician throughout.

Drug categories typically covered under Single Patient IND

Investigational oncology agents in late-phase development, post-approval expansion to indications not yet through full FDA review, investigational antivirals and antibacterials for resistant infections, rare-disease therapies in development, paediatric formulations of adult-approved medicines not yet through paediatric label expansion.

The medicine itself must be source-country approved or in active regulatory development under a recognised reference authority (typically the US FDA, the European Medicines Agency, the UK MHRA, the Japan PMDA, or Health Canada). Most destination regulators will not authorise a Single Patient IND import for a medicine that lacks a recognised reference authorisation anywhere in the world, because the regulator's risk assessment leans on the source-country review as a substitute for its own.

Country compatibility

The table below summarises how the Single Patient IND framework is recognised across the ten destination countries where Reserve Meds currently coordinates cross-border supply. The "Accepts Single Patient IND dossiers" column reflects whether the destination regulator typically reviews and grants permits on the strength of a Single Patient IND clinical justification packet, or whether the patient must use a different parallel framework on the receiving side. Timelines reflect routine cases with a complete documentation set; first-import scenarios, paediatric weight-banded presentations, advanced therapy medicinal products, and large multi-cycle quantities can extend the regulator review by several weeks.

Notes. "Indirect" means the destination regulator does not directly accept Single Patient IND authorisation as the legal basis for import but does recognise a Single Patient IND authorisation as supporting precedent within its own named-patient or compassionate-use review. "Not applicable" means the framework is not a patient-access pathway in the cross-border sense and is shown here for completeness. Regulator names: NHRA (Bahrain), EDA (Egypt), CDSCO (India), JFDA (Jordan), KDFC (Kuwait), MoPH (Lebanon), MoH-DGPADC (Oman), MoPH-DPA (Qatar), SFDA (Saudi Arabia), and EDE (United Arab Emirates, federal from 29 December 2025).

Documentation required

A Single Patient IND application is typically assembled in coordination with the treating physician, the dispensing facility, and the cross-border supply partner. The documentation set below covers the routine case; specific destination countries may require additional items (most frequently a hospital ethics committee notification for paediatric or complex cases, and an insurer pre-authorisation letter where the patient intends to seek reimbursement).

• Form FDA 3926 completed by the treating physician (or sponsor-investigator).
• Manufacturer letter of authorisation to reference the existing IND, or full IND content if the physician is acting as sponsor-investigator.
• Patient clinical history with documented serious or life-threatening condition and absence of satisfactory alternatives.
• Informed consent document compliant with 21 CFR 50.
• IRB notification (or concurrent IRB review for emergency cases).
• Treatment plan and monitoring plan.
• For cross-border supply: destination-country named-patient or compassionate-use application running in parallel.

Typical timeline

Emergency authorisation: phone or fax to the FDA, treatment may proceed immediately upon FDA verbal authorisation, with Form FDA 3926 submitted within 15 working days. Non-emergency authorisation: 30-day FDA review clock following submission of Form FDA 3926; treatment may begin on day 31 unless the FDA has objected. For cross-border patients, add the destination-country named-patient permit timeline (typically 5 to 25 business days running in parallel). End-to-end, most cross-border Single Patient IND cases complete within 4 to 8 weeks from first complete documentation.

Costs and reimbursement

21 CFR 312.8 cost recovery applies. Some manufacturers provide investigational drugs free under Single Patient IND as a managed-access policy; some charge the FDA-permitted cost-recovery price. International logistics, customs, dispensing handling, and coordinator fees are itemised separately on every firm quote. Insurer reimbursement for investigational drugs is uncommon.

Where Reserve Meds fits in

Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine access. For Single Patient IND cases, we coordinate the US-side sourcing through a DSCSA-compliant specialty channel, prepare the documentation packet your physician submits, coordinate validated cold-chain logistics with continuous temperature logging into the destination country, and assign a single named coordinator through the case. We do not replace your treating physician, we do not replace the destination-country regulator, and we do not replace your dispensing pharmacy. We coordinate the supply side so the physician can focus on patient care.

For each of the ten destination countries above, we publish a country-specific page documenting the operational realities (which dispensing facilities handle named-patient cases, how the cold chain is verified at the local airport, how the dispensing pharmacy releases the medicine, and what the typical insurer interaction looks like). Those country pages, combined with this pathway page and the specific drug pages, give the prescribing physician and the patient a coherent picture of what to expect before any commitment is made.

Our concierge fee is itemised separately on every firm quote alongside the drug acquisition cost, international logistics, customs, and dispensing pharmacy handling. The patient sees the full breakdown before deciding to proceed; we do not bundle costs and we do not charge an intake deposit. If the case cannot proceed for regulatory or supply reasons, we say so before any payment is taken.

Next step

If your treating physician has identified a clinical need that fits the Single Patient IND framework and you are weighing the cross-border route, the next step is a short intake. We confirm eligibility within 24 to 48 hours and send a documentation kit to your physician.

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