Final FDA guidance on developing MAbs for COVID-19 under EUA

The US Food and Drug Administration (FDA) yesterday issued the final guidance Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization.

The replaces the guidance issued in February 2021 titled Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency. The guidance provides updated recommendations that reflect the evolving scientific knowledge and the current state of COVID-19.

Although the COVID-19 public health emergency has expired, SARS-CoV-2 continues to circulate, and COVID-19 remains a serious health risk for some individuals. The FDA says it has issued this final guidance with updated recommendations as the agency continues to issue Emergency Use Authorizations (EUAs) for products to treat or prevent COVID-19.