FDA Issues Final Guidance on COVID-19 Convalescent Plasma

The FDA issued final guidance to provide recommendations to healthcare providers and investigators on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the public health emergency. The guidance also provides recommendations to blood establishments on collection and describes FDA’s interim compliance and enforcement policy regarding the Investigational New Drug (IND) requirements for the use of investigational convalescent plasma. This document supersedes the guidance of the same title issued in April 2020 and updated in May 2020.