If your patient is in an emergency situation where access is needed in a matter of hours or days, physicians should contact the FDA directly through its Division of Drug Information at 855-543-3784 or firstname.lastname@example.org. To request emergency access to investigational biological products regulated by the Center for Biologics Evaluation and Research (CBER) call 240-402-8010 or 800-835-4709 or email: email@example.com.
On weekends, or after 4:30pm EST weekdays, physician questions about and requests for expanded access for emergency use of drugs, biologics and other medical devices should be directed to the FDA Emergency Call Center at 866-300-4374 or 301-796-8240.
The FDA also responds to questions from patients about expanded access to investigational drugs, biologics (including gene therapies for rare diseases) and medical devices through its Office of Health and Constituent Affairs at (301) 796-8460 or PatientAffairs@fda.hhs.gov
The EA Navigator provides information and resources for non-emergency situations. Our Company Directory is a list of company-provided contact information about single-patient expanded access you can see here.
For questions concerning the Navigator website or about the Reagan-Udall Foundation for the FDA, please email firstname.lastname@example.org. Please keep in mind that we are unable to answer questions or comments about expanded access that do not pertain to the Navigator program.