Revocation of Emergency Use of a Biological Product; Availability
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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) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (ASPR/HHS) for COVID-19 convalescent plasma. FDA revoked the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.
Abstract as published in the Federal Register.
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