FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide recommendations to sponsors on the development of monoclonal antibody products targeting SARS-CoV-2, including addressing the impact of emerging variants, during the COVID-19 public health emergency.