Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for immediate implementation entitled "Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry." The purpose of this guidance is to provide FDA's recommendations to blood establishments for the submission of a Biologics License Application (BLA) for the manufacture of COVID-19 convalescent plasma intended for transfusion in patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting. The guidance also provides FDA's recommendations for investigational new drug applications (INDs) for investigational COVID- 19 convalescent plasma for transfusion.
Abstract as published in the Federal Register.
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