Food and Drug Administration (FDA) has released a final guidance document offering recommendations to sponsors on developing monoclonal antibody products targeting SARS-CoV-2 intended to prevent or treat COVID-19. Additionally, the guidance document lists the criteria needed for FDA to issue emergency use authorizations. The Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization document replaces the Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency guidance document that was published on February 22, 2021.