ABSTRACT

Updated Evidence to Support the Emergency Use of COVID-19 Convalescent Plasma - As of 9/23/2020   [open pdf - 380KB]

From the Document: "On August 23, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for COVID-19 [coronavirus disease 2019] Convalescent Plasma for the treatment of hospitalized patients with COVID-19. The issuance of this authorization followed the agency's evaluation of the totality of the available evidence regarding the safety and the efficacy of the product and the agency's finding that the product met the criteria for issuance of an EUA. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the issuance of an EUA during a declared public health emergency does not require the same evidentiary standard as required for approval or licensure of a drug or biological product.' Instead, the FD&C Act requires that the product 'may be effective' for its intended use, and that the 'potential benefits outweigh the known and potential risks.' FDA will continue to review the circumstances and appropriateness of the EUA. Four lines of evidence continue to support the emergency use of COVID-19 Convalescent Plasma at this time one month after initial issuance of the EUA: 1) historical data regarding prior experience with the use of convalescent plasma in other outbreak settings, 2) data from animal studies, 3) data that continues to emerge in the published literature from clinical studies performed during the current outbreak, and 4) results obtained from a large expanded access treatment protocol (National Expanded Program)."

Publisher:
Date:
2020-09-23
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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