UW Research
Policies, Procedures and Guidance

GUIDANCE Expanded Access

READ GUIDANCE

This webpage describes the IRB-related requirements and procedures for the mechanisms that allow expanded access to investigational drugs, devices, and biologics for clinical (not research) purposes before the items have been approved by the Food and Drug Administration (FDA) for use and marketing.
Expanded access is not the same as off-label use of an approved drug, device, or biologic.