RegulatoryAlerts Logo
RegulatoryAlerts
InsightsBlogPricingSign InStart Free Trial
All FDA (CBER) updates
FDA (CBER)
GUIDANCE DRAFT
Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen: Draft Guidance for Industry
Published: 7/15/2025Detected: 3/25/2026

Summary preview

Recommends how blood establishments and testing developers should test donated blood for Hepatitis B surface antigen (HBsAg) to strengthen transfusion safety.

Get the full analysis, free

Create a free account to see the complete summary, key takeaways, and why this matters for your products, and to get alerts like this by email.

Create free account
infectious_disease
safety
#CBER
#draft guidance
#blood donation testing
#hepatitis B
#HBsAg

Official Source Document
Source Verified

Access the original document directly from FDA CBER.

View Official Document

More from FDA (CBER)

  • Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method9/16/2026
  • Potency Assessment of Active Immunotherapy Products8/19/2026
  • Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products: Guidance for Industry8/19/2026
  • Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus: Guidance for Industry6/29/2026
  • Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing6/2/2026

Get FDA (CBER) alerts in your inbox as they are published.

Free plan, 2-minute setup, no credit card required.

RegulatoryAlerts Logo
RegulatoryAlerts

Automated regulatory intelligence monitoring for pharmaceutical and biotech professionals. Track FDA, EMA, and Health Canada updates seamlessly.

Product

  • Insights
  • Updates by Therapeutic Area
  • FDA Updates
  • EMA Updates
  • Pricing
  • Features
  • Request Demo

Resources

  • Integration Guides
  • Regulatory Glossary
  • EMA Timeline
  • Best Practices
  • Therapeutic Areas

Company

  • About Us
  • Blog
  • Contact
  • Security
  • Privacy Policy
  • Terms of Service
  • © 2026 RegulatoryAlerts. All rights reserved.

    Not affiliated with the FDA, EMA, or Health Canada.