Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry; Availability
What this record is not
Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
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.
READ THE FULL DOCUMENT
The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →That is what FDA published. A free account files it on your watchlist and sends one weekly email with whatever lands next.
Create a free account