FDA continues to process Expanded Access requests for investigational products.
Project Facilitate remains open at (240) 402-0004 or
ONCProjectFacilitate@fda.hhs.gov from 8 a.m. to 4:30 p.m. Eastern time, Monday through Friday, to assist oncology health care providers and regulatory professionals in requesting
access to investigational therapies for patients for the treatment of cancer when no satisfactory therapies are available and there is no opportunity for the patient to enroll in a clinical trial. For after-hours emergency requests, contact FDA's Emergency Call Center at 1-800-300-4374.
Health care providers caring for patients with cancer and COVID-19 who are seeking an
investigational treatment specifically to treat COVID-19 should contact the
Division of Antivirals or CBER directly to request access. Patients and caregivers who need information about accessing investigational therapies may contact the Division of Drug Information at (301) 796-3400 or email
druginfo@fda.hhs.gov.