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. The request may be made by fascimile with a letter to follow.

1. Request for a single patient IND for Compassionate or Emergency Use should be stated at the top of the correspondence.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. FDA Form 1571 completed with the treating physician listed as the sponsor. Form 1571 and other forms can be downloaded from the Internet.
8. Contact telephone number and facsimile number. If the request is approved, an IND number will be issued by the FDA and the treating physician will be contacted by phone or fax 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 the appropriate Review Division.

Office or Division	Phone	Fax
Division of Antiviral Products	(301)  796-1500	(301)  796-9883
Division of Cardiovascular and Renal Products	(301)  796-2270	(301)  796-9840
Division of Neurology Products	(301)  796-2250	(301)  796-9839
Division of Psychiatry Products	(301)  796-2260	(301)  796-9841
Division of Oncology Products 1	(301)  796-2330	(301)  796-9845
Division of Oncology Products 2	(301)  796-2320	(301)  796-9849
Division of Reproductive and Urologic Products	(301)  796-2130	(301)  796-9897
Division of Hematology Products	(301)  796-7550	(301)  796-9849
Division of Medical Imaging Products	(301)  796-2050	(301)  796-9848
Division of Gastroenterology and Inborn Errors Products	(301)  796-2120	(301)  796-9905
Division of Anesthesia, Analgesia, and Addiction Products	(301)  796-2280	(301)  796-9723
Division of Metabolism and Endocrinology Products	(301)  796-2290	(301)  796-9712
Division of Pulmonary, Allergy and Rheumatology Products	(301)  796-2300	(301)  796-9728
Division of Dermatolgy and Dental Products	(301)  796-2110	(301)  796-9895
Division of Anti-Infective Products	(301)  796-1400	(301)  796-9883
Division of Transplant and Ophthalmology Products	(301)  796-1600	(301)  796-9840