💊FDA Revokes Emergency Use Authorizations for Specific Drug Products
Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
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 Cosmetic Act (FD&C Act). The revocations, including an explanation of the reasons for the revocations, are reprinted in this document.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The revocation of Emergency Use Authorizations (EUA) for drugs affects business owners in the healthcare sector, particularly the companies involved (Fresenius and Baxter), as they must halt production and distribution. This could lead to financial losses and compliance challenges under the FD&C Act.