For Physicians: How to Request Single Patient Expanded Access (“Compassionate Use”)
When a physician wants to submit a Single Patient Expanded Access request to obtain an unapproved investigational drug for an individual patient, he or she must first ensure that the manufacturer is willing to provide the investigational drug for expanded access use. If the manufacturer agrees to provide the drug, the physician should follow the steps below to submit an Investigational New Drug Application (IND) to the FDA.
Emergency Requests:
In an emergency situation, the request to use an unapproved investigational drug may be made via telephone or other rapid means of communication, and authorization to ship and use the drug may be given by the FDA official over the telephone. In these situations, known as emergency IND (eIND) requests, shipment of and treatment with the drug may begin prior to FDA’s receipt of the written IND submission that is to follow the initial request. An emergency IND timeline is available online to guide you through the process.
Non-emergency Requests:
In a non-emergency situation, a written request (IND) for individual patient use of an investigational drug must be submitted to the FDA. The investigational drug may be shipped and treatment of the patient may begin 30 days after the application is received by FDA or earlier if notified by the FDA that treatment may proceed. These non-emergency requests are known as individual patient INDs, or single patient expanded access requests. A guide to initiate and maintain non-emergency requests is available for physicians online.
Form FDA 3926 is designed specifically for use by physicians when submitting requests for single patient expanded access to investigational drugs, including in emergencies. It is also for certain subsequent submissions to FDA after the initial application is received. 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. For more information, including instructions, please visit the guidance Individual Patient Expanded Access Applications: Form FDA 3926.
- Physicians are still able to use Forms 1571 and 1572 for single patient expanded access submissions; however, Form 3926 was developed specifically for these requests. Form FDA 1571 and 1572 are still required for other expanded access submissions involving more than one patient (e.g., intermediate access or treatment INDs) and for IND submissions by commercial sponsors or drug manufacturers.
Upon receipt of the single patient expanded access application, FDA will review to make a decision. The FDA will either allow the treatment to proceed or place the IND on hold. FDA allows over 99% of single patient expanded access requests to proceed. FDA may contact the physician to request more information or clarification in order to avoid placing the IND on hold.
Treatment with the drug may proceed 30 days after FDA receives the IND submission or upon notification of the physician by FDA, whichever comes first. IRB approval and informed consent must be obtained before treatment begins. If the treatment use is not allowed to proceed (i.e., a clinical hold is placed on the application), FDA will notify the physician of this decision initially via a telephone call. The call will be followed by a written letter that provides the reasons for FDA's denial of the request.
Active INDs will be assigned an IND number. The drug supplier may request the IND number in order to ship the drug to the treating physician.
How to Submit Single Patient Expanded Access Applications
Submit by mail:
Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room
ATTN: [appropriate Review Division]
“EXPANDED ACCESS SUBMISSION”
5901-B Ammendale Rd.
Beltsville, Md. 20705-1266
For other submission options, contact FDA using the information below. Please call or e-mail before faxing documents.
Questions?
|
Type of Request |
Weekday M-F 8:00 – 4:30 pm ET |
After hours, weekends, and holidays |
|---|---|---|
|
Emergency Requests |
Contact the appropriate review division below, if known. If unknown, contact the Division of Drug Information: 855-543-3784, or |
Emergency Coordination Staff: 866-300-4374, or |
|
Non-emergency Requests |
Division of Drug Information: 855-543-3784, or |
Division of Drug Information: 855-543-3784, or |
CDER Review Divisions, organized by Office of Drug Evaluation
|
CDER Review Division |
Telephone Number |
FAX Number |
|---|---|---|
|
Not sure which review division is appropriate? |
855-543-3784 |
301-431-6353 |
|
Office of Drug Evaluation I |
||
|
Division of Cardiovascular and Renal Products |
301-796-2240 |
301-796-9841 |
|
Division of Neurology Products |
301-796-2250 |
301-796-9842 |
|
Division of Psychiatry Products |
301-796-2260 |
301-796-9838 |
|
Office of Drug Evaluation II |
||
|
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 |
|
Office of Drug Evaluation III |
||
|
Division of Gastroenterology and Inborn Errors Products |
301-796-2120 |
301-796-9904 |
|
Division of Dermatology and Dental Products |
301-796-2110 |
301-796-9895 |
|
Division of Reproductive and Urologic Products |
301-796-2130 |
301-796-9897 |
|
Office of Drug Evaluation IV |
||
|
Division of Medical Imaging Products |
301-796-2050 |
301-796-9899 |
|
Division of Nonprescription Drug Products |
301-796-2060 |
301-796-9899 |
|
Office of Antimicrobial Products |
||
|
Division of Antiviral Products |
301-796-1500 |
301-796-9883 |
|
Division of Anti-Infective Products |
301-796-1400 |
301-796-9881 |
|
Division of Transplant and Ophthalmology Products |
301-796-1600 |
301-796-9880 |
For oncology/hematology Expanded Access requests, healthcare providers may call the Oncology Center of Excellence Project Facilitate at 240-402-0004, or email OncProjectFacilitate@fda.hhs.gov. See Project Facilitate for further information.