FDA Updates Guidance Agenda

The U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has published an update to its guidance agenda for 2023. The agenda outlines the guidance and draft guidance documents that CBER “is considering for development” throughout the calendar year.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 and that were included in FDA updates to the Guidance Agenda are:

• “Collection of Platelets by Automated Methods; Draft Guidance for Industry;
• Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry;
• Blood Pressure and Pulse Donor Eligibility Requirements; Compliance Policy; Guidance for Industry; [and]
• Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry.”

Topics categorized as tissue and advanced therapies that may be of interest include:

• “Considerations for the Use of Human- and Animal- Derived Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Draft Guidance for Industry;
• Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry;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for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry;
• Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry; [and]
• Potency Assurance for Cellular and Gene Therapy Products, Draft Guidance for Industry.”

America’s Blood Centers will continue to provide updates to member blood centers on its advocacy efforts regarding the CBER guidance agenda as they become available.