REGULATORY UPDATE: FDA Releases 2024 Guidance Agenda

The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has released its guidance agenda for 2024, which includes topics CBER is considering for development during the calendar year. AABB appreciates CBER’s plans to address many long-term issues of great interest related to blood and biotherapies.

In the category of “Blood and Blood Components,” CBER lists five documents, including three carried over from 2023. The five planned documents are as follows:

• 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Blood Collection, Processing and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Draft Guidance for Industry.
• Collection of Platelets by Automated Methods; Draft Guidance for Industry (carried over from 2023).
• Blood Pressure and Pulse Donor Eligibility Requirements; Compliance Policy; Guidance for Industry (carried over from 2023).
• Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry (carried over from 2023).

In the category of “Therapeutic Products,” CBER plans 10 guidances. The list includes five new guidances and five carried over from 2023.

• 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.
• Frequently Asked Questions — Cell and Gene Therapy Products; Draft Guidance for Industry.
• 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Derived Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Draft Guidance for Industry (carried over from 2023).
• Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry (carried over from 2023).
• Recommendations for Determining Eligibility of Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry (carried over from 2023).
• Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Guidance for Industry (carried over from 2023).
• Potency Assurance for Cellular and Gene Therapy Products, Guidance for Industry (carried over from 2023).
• 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.

In the “Other” category, CBER plans one guidance, “Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions,” which is carried over from 2023.

The AABB Newsfeed will include additional information as FDA releases these guidances. Members with questions may contact regulatory@aabb.org.