Regulation Brief November 3, 2026, 3:00 AM ET

FDA releases final guidance on reducing transfusion-transmitted Hepatitis B virus

FDA announces availability of the final guidance titled "Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus" on November 3, 2026. The guidance supersedes several earlier documents and applies to the collection of Whole Blood and blood components, including Source Plasma.

Primary source

Federal Register notice, November 3, 2026

Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus; Guidance for Industry; Availability

Read the source: Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus; Guidance for Industry; Availability federalregister.gov

By The Priority Review desk. Machine-summarized from the source above; not independently reported. How we use automation