CBER 2024 Guidance Agenda Announced

The U.S. Food and Drug Administration’s (FDA) has published the Center for Biologics Evaluation and Research (CBER) 2024 Guidance Agenda on the agency’s website. The agenda outlines the guidance and draft guidance documents that CBER “is considering for development” throughout the calendar year.

Topics of note in the CBER 2024 guidance agenda that the agency will look to address include:

• “Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry;
• Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Draft Guidance for Industry;
• Collection of Platelets by Automated Methods; Draft Guidance for Industry;
• Blood Pressure and Pulse Donor Eligibility Requirements; Compliance Policy; Guidance for Indus-try; [and]
• Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry.”

Topics categorized as therapeutic products in the CBER 2024 guidance agenda that may be of interest included:

• “Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry;
• Considerations for the Development of Chimeric Antigen Receptor T Cell Products; Guidance for Industry;
• Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry;
• Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry;
• Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Guidance for Industry;
• Potency Assurance for Cellular and Gene Therapy Products, 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; [and]
• 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.”