Drugs

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.

Back to Top


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
301-796-3400
301-431-6353 (fax)
druginfo@fda.hhs.gov

Emergency Coordination Staff:

866-300-4374, or
301-796-8240
fax: 301-431-6356
CDER-EIND@fda.hhs.gov

Non-emergency Requests

Division of Drug Information:

855-543-3784, or
301-796-3400
fax: 301-431-6353
druginfo@fda.hhs.gov

Division of Drug Information:

855-543-3784, or
301-796-3400
fax: 301-431-6353
druginfo@fda.hhs.gov

Back to Top


CDER Review Divisions, organized by Office of Drug Evaluation

CDER Review Division

Telephone Number

FAX Number

Not sure which review division is appropriate?
Call the Division of Drug Information

855-543-3784
301-796-3400

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

Office of Oncology and Hematology Products

Division of Oncology Products 1

301-796-2330

301-796-9845

Division of Oncology Products 2

301-796-2320

301-796-9849

Division of Hematology Products

301-796-7550

301-796-9849

Back to Top

Page Last Updated: 07/26/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English