With the December ARROW patch, applications for Humanitarian Use Devices (HUDs) and Expanded Access Requests (emergency uses, single-patient, and patient group expanded access/compassionate uses) will be stand-alone application types in the application wizard. In addition, to take advantage of flexibility in the review process for non-emergent single-patient expanded access requests, the Expanded Access application will ask treating teams if they have requested a waiver from convened board review from the FDA. If the appropriate request has been made and documentation uploaded, these submissions will no longer require review by the convened board and can instead be reviewed by the Chair or designee.
Review Flexibility for Single-Patient Expanded Access Requests
December 15, 2021