Covid-19 Monoclonal Antibody EUA Guidance

FDA has published an immediately effective guidance, Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization, with recommendations for sponsors on developing monoclonal antibody products intended to prevent or treat Covid-19, including recommendations on addressing the impact of emerging variants. The document says that while circumstances have improved, SARS-CoV-2 remains in broad circulation throughout the U.S.

“FDA is publishing this guidance to provide its current recommendations on the data and information that may be used to support a request for an emergency use authorization … for a monoclonal antibody product for the prevention or treatment of Covid-19,” the guidance says. The guidance is intended to be effective only for the duration of the 3/27/2020 declaration of the HHS secretary that circumstances exist justifying the authorization of emergency use of drugs and biological products during the Covid-19 pandemic.