FDA Updates Sotrovimab Emergency Use Authorization
FDA has revised the Emergency Use Authorization for sotrovimab.
FDA updated the Emergency Use Authorization (EUA) for sotrovimab on Feb. 23, 2022 to clarify that sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a variant that is not susceptible to this treatment.
This update is in response to FDA’s continuous monitoring of how authorized treatments for COVID-19 are affected by changing variants, which currently include the Omicron variant and Omicron sub-variants.
Sotrovimab is still currently authorized in all US regions. The EUA authorizes sotrovimab to treat positive-testing patients who are at high risk for progression to severe COVID-19, including hospitalization or death. Sotrovimab should be administered via IV as soon as possible after a positive viral test for COVID-19 and within seven days of symptom onset.
FDA will continue to monitor conditions and refer to available information to determine whether use in a geographic region is feasible for authorization.
Source: FDA
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
