Expanded Access
Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Expanded access may be appropriate when all the following apply:
- Patient has a serious or immediately life-threatening disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
Investigational drugs, biologics or medical devices have not yet been approved or cleared by FDA and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.
Information for Patients, Physicians, Industry and Institutional Review Boards
Learn about expanded access, including information about the expanded access process, what FDA considers, and what costs may be involved.
Learn about expanded access, including information about the different types of expanded access, how to submit expanded access requests, and reporting requirements.
Learn about expanded access, including information about posting your expanded access policy, how to submit expanded access requests, and reporting requirements.
Learn about expanded access, including information about Institutional Review Board (IRB) review, approval and reporting.
Learn about how to complete and submit forms needed for each type of expanded access request.
Key Contact Information
1. During Normal Business Hours (8 a.m. - 4:30 p.m. ET, weekdays)
For emergency requests and specific questions during normal business hours:
- Investigational drugs: 301-796-3400 or druginfo@fda.hhs.gov [CDER's Division of Drug Information], or contact the appropriate review division, if known
- Oncology drugs: 240-402-0004 or ONCProjectFacilitate@fda.hhs.gov
- Investigational medical devices: 301-796-7100 or DICE@fda.hhs.gov [CDRH's Division of Industry and Consumer Education]
- Investigational biologics: 240-402-8020 or 800-835-4709 or industry.biologics@fda.hhs.gov [CBER's Office of Communication, Outreach and Development]
For general questions, or if you are unsure of who to contact, contact the Patient Affairs Staff at 301-796-8460 or patientaffairs@fda.hhs.gov.
2. After 4:30 p.m. ET weekdays and all day on weekends
For emergency requests for all medical products (drugs, biologics, and medical devices) contact FDA's Emergency Call Center at 866-300-4374.