COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity

Due to the current public health emergency, FDA is issuing this guidance to assist sponsors in the development of monoclonal antibodies (mAbs) and other therapeutic proteins for use as COVID-19 therapeutics.

Source: FDA Center for Drug Evaluation and Research - What's New - January 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news