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.
- 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).
- FDA Form 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 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 CDER’s Division of Drug Information (DDI) at phone: 301-796-3400 or 855-543-3784; fax: 301-431-6353; or e-mail: email@example.com or 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|
Contact Information for Emergency Single Patient INDs
During normal business hours (8 am – 4:30 pm EST weekdays)
For general questions about expanded access for emergency use for investigational drugs, contact CDER’s Division of Drug Information (DDI) at phone: 301-796-3400 or 855-543-3784; fax: 301-431-6353; or e-mail: firstname.lastname@example.org.
For questions about expanded access for emergency use for a specific investigational drug, contact the appropriate review division, if known, or DDI, if not known.
If DDI and the review division are not available, contact the CDER Emergency Coordinator (CEC) of the Counter-Terrorism and Emergency Coordination Staff (CTECS) at phone: 301-796-9900 or 301-796-2210; fax*: 301-431-6356; or e-mail at : email@example.com . * Please call or e-mail the CDER Emergency Coordinator before faxing documents.
After hours (after 4:30 pm EST weekdays and all day on weekends)
All questions about and requests for expanded access for emergency use for drugs, biologics and medical devices should be directed to the FDA Emergency Call Center, telephone: 866-300-4374.