Vaccines, Blood & Biologics

Expanded Access to Experimental Biologics

Clinical trials are studies of drugs and biologics that are still in development and have not yet been approved by the FDA. Many patients enroll in clinical trials to gain access to investigational therapies and contribute to finding out how well an investigational therapy works, and how safe it is for patients. Obtaining a drug or biologic under an expanded access program may be an option for some patients who are not able to enroll in clinical trials. The FDA has allowed expanded access to experimental drugs and biologics since the 1970s. That access has allowed tens of thousands of patients with HIV/AIDS, cancer, and other conditions to receive promising therapies when no approved alternative is available.

Emergency Requests
If there is an emergency that requires the patient to be treated before a written submission can be made, FDA may allow the treatment use to proceed without a written submission, provided the applicable criteria are met. In an emergency situation, the request to use the drug may be made via telephone, fax, or other means of electronic communication, and authorization to ship and use the drug may be given by the FDA official over the telephone.

During normal business hours (8 am – 4:30 pm EST weekdays)
  • For all other investigational drugs, call 301-796-3400 or 855-543-3784
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 or 301-796-8240.


Key Resources

  • Expanded Access
    This section of our website provides complete information about FDA’s current expanded access policies, requirements for enrolling in expanded access programs, and steps you can take to get more information.
  • CBER Expanded Access Submission Receipt Reports
    This section includes data on CBER’s Expanded Access Performance.

Page Last Updated: 08/31/2018
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