COVID-19 Convalescent Plasma Guidance Updated

The U.S. Food and Drug Administration (FDA) issued new guidance (FDA-2020-D-1825) to provide recommendations to healthcare providers and investigators on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the COVID-19 public health emergency.

The guidance published on March 13, 2023, also provides recommendations to blood establishments on collection.

This FDA document supersedes the guidance of the same title issued in January 2021 (previous versions November 2020, September 2020, May 2020, and April 2020).

COVID-19 convalescent plasma is not a vaccine nor a monoclonal antibody therapeutic.