[3] It also provides a description of, and clinical rationale for, the EUA-approved drugs during the pandemic and concluding reflections on the EUA program and its potential future uses.
Furthermore, drugs, devices or biologic products may or may not have undergone human efficacy trials, due to risk, feasibility or ethical considerations.
Under certain conditions, an EUA may authorize the emergency use in humans, of drugs, devices or biologic products approved under the animal efficacy rule.
In response to requests from the U.S. Centers for Disease Control and Prevention (CDC), on April 27, 2009, the FDA issued Emergency Use Authorizations to make available diagnostic and therapeutic tools to identify and respond to the 2009 swine flu pandemic under certain circumstances.
[4] On February 4, 2020, in response to the COVID-19 pandemic, the Secretary of HHS declared the public health emergency for the novel SARS-CoV-2 virus, which causes the disease COVID-19, for deployment of the FDA EUA for certain medical devices involved in the diagnosis of COVID-19.
[6] In 2020, the FDA issued EUAs for remdesivir,[7][8] convalescent plasma, Fresenius Propoven 2% emulsion (propofol), hydroxychloroquine (revoked, although its license for established indications remains), and bamlanivimab – all in response to the COVID-19 pandemic.
[3] On April 16, 2021, the FDA revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients.