USA – FDA releases assay guidance for COVID-19 antibody drugs

Amid the coronavirus pandemic, the US Food and Drug Administration has issued guidance on potency assays for manufacturers of monoclonal antibodies and other therapeutic proteins to treat COVID-19. The guidance is immediately effective for the duration of the public health emergency.

In the ordinary course of business, FDA would have engagement with drug developers to work on potency assays “over a span of years.” However, according to the guidance, “given the compressed development timelines associated with therapeutics intended to treat COVID-19, FDA is issuing this guidance to provide more detailed recommendations to drug developers with the goal of facilitating more complete submissions.”…