FDA revises guidance on convalescent plasma

Feb. 15, 2021

The U.S. Food and Drug Administration (FDA) has revised its guidance, Investigational COVID-19 Convalescent Plasma, and associated web page to reflect a reissued emergency use authorization for COVID-19 convalescent plasma.

The guidance provides recommendations to blood establishments on the collection and labeling of high titer COVID-19 convalescent plasma under the EUA. Specifically, the FDA said the COVID-19 convalescent plasma units must be clearly labeled as high titer COVID-19 convalescent plasma based on the results of the SARS-CoV-2 antibody test used as part of manufacturing. This information may be placed on the container label or on a tie tag.

In addition, the FDA’s revisions explain that people who have received COVID-19 monoclonal therapy do not qualify as donors of convalescent plasma until at least three months have past since they received the treatment.

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