Recently Posted FDA Guidance Document: COVID-19 Convalescent Plasma

Investigational COVID-19 Convalescent Plasma: Guidance for Industry

On August 23, 2020, FDA issued an Emergency Use Authorization (EUA)  for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19.  FDA has subsequently reissued this EUA with revisions.   FDA recognizes that while COVID-19 convalescent plasma may be used under an EUA consistent with the authorization, COVID-19 convalescent plasma may also be used under an investigational new drug application (IND).  For the purposes of this guidance, the term “COVID-19 convalescent plasma” refers to the convalescent plasma authorized under the EUA, while the term “investigational convalescent plasma” refers to convalescent plasma that does not meet all the conditions of the EUA and/or is being used under an IND.

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