Update of the Overview of upcoming CBER Guidelines in 2024

At regular intervals, the FDA's Center for Biologics Evaluation and Research (CBER) publishes an overview of the new guidelines planned for publication in the current financial year in areas in which no documents currently exist, of guidelines that exist but are now to be revised and of guidelines of which drafts already exist and which can now be finalised following evaluation of the comments received. The list represents a plan, a declaration of intent, but is not binding and topics may be omitted for the time being and guidelines on other topics may be revised.
Below you will find an overview of the guidelines mentioned.

Category Blood and Blood Components

• 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Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Draft Guidance for Industry
• Collection of Platelets by Automated Methods; Draft Guidance for Industry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 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• Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry
• Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry

Category Therpeutical Products

• Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry (Published 1/30/2024)
• Considerations for the Development of Chimeric Antigen Receptor T Cell Products; Guidance for Industry (Published 1/30/2024)
• Frequently Asked Questions — Cell and Gene Therapy Products; Draft Guidance for Industry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Derived Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Draft Guidance for Industry (Published 4/30/2024)
• Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry (Published 4/30/2024)
• Accelerated Approval of Human Gene Therapy Products for Rare Diseases; Draft Guidance for Industry
• Use of Platform Technologies in Human Gene Therapy Products Incorporating Human  Genome Editing; Draft Guidance for Industry
• Potency Assessment of Therapeutic Vaccines; Draft Guidance for Industry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
• Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry

Category Other

• 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 (Published 6/5/2024)

The complete  agenda of the CBER can you find directly at CBERs website.