Centers for Disease Control and Prevention, it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.
The Food and Drug Administration has issued an Emergency Use Authorization (EUA) for a another diagnostic test for the 2009 H1N1 influenza, -- better known as swine flu -- virus, whose spread has caused the virus to be characterized as a pandemic by the World Health Organization.
3 Furthermore, "products are eligible for emergency use authorization if FDA determines that the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product.
Today's declaration, made under section 319 of the Public Health Service Act, will help HHS prepare for prevention and mitigation activities by enabling Food and Drug Administration (FDA) emergency use authorizations of drugs, devices, or medical tests under certain circumstances.
