The 2024 guidance agenda has been updated by the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) . The agenda outlines the guidance and draft guidance documents that CBER “is considering for development” throughout the calendar year. A new addition to the guidance agenda is, “Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry.” This comes in the wake of FDA’s May 2024 BPAC Meeting on, “strategies to reduce the risk of transfusion-transmitted malaria by testing blood donations from donors at risk of malaria exposure.” ABC previously submitted comments to FDA ahead of the meeting with malaria testing recommendations.
Other topics of note in the 2024 updated guidance agenda from CBER that agency will look to address include:
- “Collection of Platelets by Automated Methods; Draft Guidance for Industry;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- Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry.”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 2024 in the updated guidance agenda from CBER include:
- “Accelerated Approval of Human Gene Therapy Products for Rare Diseases; Draft Guidance for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of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry;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of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry; [and]
- 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of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry.”
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. The complete listing of the potential guidances is updated periodically throughout the year and always available on the FDA’s website.