ABSTRACT

Investigational COVID-19 Convalescent Plasma: Guidance for Industry [September 2, 2020]   [open pdf - 346KB]

From the Introduction: "FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. 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 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. FDA is issuing this guidance to provide recommendations to health care providers and investigators on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the public health emergency. The guidance also provides recommendations to blood establishments on collection. We also describe FDA's interim compliance and enforcement policy regarding the IND requirements for the use of investigational convalescent plasma. This document supersedes the guidance of the same title issued in April 2020 and updated in May 2020."

Publisher:
Date:
2020-09-02
Series:
Copyright:
Public Domain
Retrieved From:
U.S. Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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