Physician Request for a Single Patient IND for Compassionate or Emergency Use
When a physician would like to request an Investigational New Drug (IND) application to use an unapproved drug or other product for a single patient, the first step is to obtain permission from the manufacturer. Without the consent of the manufacturer, the unapproved product will not be available to the patient. After the manufacturer agrees to provide the product, the recommended procedure is to submit the following information to the appropriate review division.
- Request for a single patient IND for Compassionate or Emergency Use should be stated at the top of the correspondence.
- Brief Clinical History of the patient including the diagnosis, the disease status, prior therapy, response to prior therapy and the rationale for requesting the proposed treatment.
- Proposed Treatment Plan including the dose, route, planned duration, monitoring procedures and modifications (e.g. dose reduction or treatment delay) for toxicity. Reference a published protocol or journal article if appropriate.
- Drug Supply Reference Statement which would name the supplier or manufacturer and a statement that a Letter of Authorization to cross reference an appropriate IND of the supplier or Drug Master File (DMF) of the manufacturer is included. The treating physician must contact the supplier or manufacturer for such a statement.
- Informed Consent Statement that states that informed consent and approval of an appropriate Institutional Review Board (IRB) will be obtained prior to initiating treatment. There are some IRBs that have specific procedures for approving emergency requests.
- Investigator Qualification Statement that specifies the training, experience, and licensure of the treating physician. The first two pages of a Curriculum Vitae typically contain this information and are usually sufficient.
- Form FDA 3926 can be used by physicians when submitting requests for individual patient expanded access to investigational drugs, including in emergencies. This form is designed specifically for single patient IND requests. It can also be used for certain submissions to FDA after the initial application is filed (if you have trouble opening this form you may need to open it in Internet Explorer or right click on the form and save it as a PDF).
- Form FDA 1571 and 1572 are no longer required for individual patient expanded access to investigational drugs and biologics. Form FDA 1571 and 1572 are still required for other expanded access submissions (e.g., intermediate access or treatment INDs) and for IND submissions by commercial sponsors or drug manufacturers.
- Contact telephone number. If the request is approved, an IND number will be issued by the FDA and the treating physician will be contacted typically by phone or other electronic means of communication, with a letter to follow. The IND is considered active upon issuance of the number. The IND sponsor (treating physician) will then contact the drug supplier and provide the IND number. The supplier may then ship the drug directly to the treating physician.
For further information, please contact CDER’s Division of Drug Information (DDI) at phone: 301-796-3400 or 855-543-3784; or e-mail: firstname.lastname@example.org or the appropriate Review Division.
Contact Information for Emergency Single Patient INDs is also available on FDA’s Expanded Access Contact Us page.