2025 CBER Guidance Agenda Available

The U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has published its 2025 guidance agenda. The agenda outlines the guidance and draft guidance documents that CBER “is considering for development” throughout the calendar year. Topics of note that the agency will look to address in the 2025 CBER Guidance Agenda include:

• “Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Guidance for Industry;
• Collection of Platelets by Automated Methods; Draft Guidance for Industry;
• Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry;
• Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry; [and]
• Recommendations for the Evaluation of Blood Collection, Processing, and Storage Devices Using Non-Di(2-ethylhexyl) Phthalate (non-DEHP) Materials: Draft Guidance for Industry.”

Topics categorized as therapeutic products that may be of interest in the 2025 CBER Guidance Agenda include:

• “Frequently Asked Questions — Cell and Gene Therapy Products; Guidance for Industry;
• Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Guidance for Industry;
• Post Approval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry;
• Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry;
• Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry;
• Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry;
• Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry;
• Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry; [and]
• Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry.”

America’s Blood Centers (ABC) will continue to provide updates to member blood centers on its advocacy efforts regarding the 2025 CBER Guidance Agenda as they become available.