This guidance describes the circumstances regarding Expanded Access Emergency Use (Emergency Use) of an investigational product (drug, biologic, or device) and the procedures to be followed before or immediately following the emergency use of an investigational product.
Emergency Use is part of the FDA Expanded Access program. See also the IRBMED Expanded Access guidance page. Ordinarily, FDA regulations require prior approval by the FDA and an IRB, and informed consent, for the administration of an investigational drug, biologic, or device. Exceptions to this rule apply in very limited cases, including serious or immediately life-threatening emergencies: in an Emergency Use, some of these requirements may be met after the fact.