USA – Guidance : Investigational COVID-19 Convalescent Plasma

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the
United States (U.S.) from threats including emerging infectious diseases, such as the
Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely
guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide recommendations to health care providers and
investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. The guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma.

The recommendations in this guidance are intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act)…