FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: REVOCATION OF EMERGENCY USE OF A DRUG PRODUCT DURING THE COVID-19 PANDEMIC; AVAILABILITY

WASHINGTON, May 21 -- Food and Drug Administration has issued a notice called: Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability.

The notice was published in the Federal Register on May 21 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Fresenius Medical Care North America (Fresenius) for multiFiltrate PRO System and multiBic/multiPlus solutions (EUA 048), and to Baxter Healthcare Corp. (Baxter) for REGIOCIT (EUA 068). FDA revoked the Authorizations on January 16, 2025, under the Federal Food, Drug, and Cosme...