Serious and unexpected adverse events must be reported to FDA. This link provides guidance on reporting or you can download an IND safety report Form FDA 3500A for non-emergency Expanded Access. The same requirements that apply to clinical trials (21 CFR 312.32) apply to expanded access to the extent they are applicable. Electronic submission is not mandatory for Expanded Access INDs but is encouraged and explained here. For help filling out Form FDA 3500A, physicians are encouraged to contact the FDA's Division of Drug Information at 855-543-3784 or druginfo@fda.hhs.gov.