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GUIDANCE DOCUMENT

Investigational COVID-19 Convalescent Plasma Guidance for Industry January 2022

Final
Docket Number:
FDA-2020-D-1825
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance is intended to remain in effect until November 7, 2023, unless superseded by a revised final guidance before that date. For further information, refer to 85 FR 15417, March 13, 2023, and https://www.federalregister.gov/documents/2023/03/13/2023-05094/guidance-documents-related-to-coronavirus-disease-2019-covid-19.

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 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.

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 January 2021 (previous versions November 2020, September 2020, May 2020, and April 2020).  We have revised the recommendations in section III.B.1 of this guidance pertaining to convalescent plasma donors.  The revisions address when individuals who have received an investigational COVID-19 monoclonal antibody therapy as a participant in a clinical trial, or received an authorized or licensed COVID-19 monoclonal antibody therapy, qualify as convalescent plasma donors.  We also revised the recommendations in section III.B.2 and 3 of the guidance pertaining to the qualification and labeling of high titer COVID-19 convalescent plasma under the EUA.  In addition, we updated section IV of the guidance to note that FDA intends to exercise enforcement discretion related to the investigational new drug requirements for use of convalescent plasma including when, among other circumstances, the donor meets the qualifications for individuals who have received a COVID-19 vaccine or COVID-19 monoclonal antibody therapy in accordance with section III.B.1 of this guidance.

 


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1825.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
[email protected]
(800) 835-4709
(240) 402-8010
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