FDA In Brief: FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data
SILVER SPRING, Md., Feb. 4, 2021 /PRNewswire/ -- The following quote is attributed to Peter Marks, M.D., Ph.D., Director of FDA's Center for Biologics Evaluation and Research:
"The FDA is issuing a revision of the Emergency Use Authorization (EUA) for COVID-19 convalescent plasma as a result of our evaluation of the most recent information available. Based upon data from new clinical trials analyzed or reported since the original EUA was issued in August 2020, we have revised the EUA to limit the authorization to the use of high titer COVID-19 convalescent plasma for the treatment of hospitalized patients early in the disease course. This and other changes to the EUA represent important updates to the use of convalescent plasma for the treatment of COVID-19 patients.
Issuance of, and updates to, EUAs are based on a thorough evaluation of currently available scientific evidence about medical products. In this case, as additional scientific evidence about COVID-19 convalescent plasma emerged, we revised the EUA to reflect the updated evidence. COVID-19 convalescent plasma used according to the revised EUA may have efficacy and its known and potential benefits outweigh its known and potential risks."
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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SOURCE U.S. Food and Drug Administration