In certain types of emergencies, the HHS Secretary may issue a determination and declaration under the Food Drug and Cosmetic Act that permits the FDA to issue EUAs to facilitate access to medical countermeasures (drugs, biologics, vaccines, and devices) that can be used to diagnose, treat, or prevent a serious disease or condition in a public health emergency.
Products authorized for use in this way might not be approved by the FDA for any use, or they might be approved for other uses but not for the emergency use. The FDA decides whether the use of the product is likely to be more helpful than harmful for the emergency use; i.e., the agency determines that the known and potential benefits of the medical products for their intended uses outweigh their known and potential risks. This authorization is reserved for emergency situations and is not the same as FDA approval or licensure.
This authorization is reserved for emergency situations and is not the same as FDA approval or licensure.
Below is more information about the EUA for REGEN-COV.