REGULATORY UPDATE: FDA Revises 2024 CBER Guidance Agenda

The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) issued a July update to the 2024 Guidance Agenda.

In the “Blood and Blood Components” category, FDA added the guidance “Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry.”

In the “Therapeutic Products” category, FDA removed the guidance “Potency Assurance for Cellular and Gene Therapy Products” and added the following guidances:

• Accelerated Approval of Human Gene Therapy Products for Rare Diseases; Draft Guidance for Industry.
• Use of Platform Technologies in Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry.
• Potency Assessment of Therapeutic Vaccines; Draft Guidance for Industry.

  Also, under the “Therapeutic Products” category, FDA removed the proposed draft guidance “Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” and added the following:

• 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of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry.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of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry.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of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry. 

The remainder of the guidances CBER is considering for development during calendar year 2024 is unchanged.

AABB invites members with questions to contact regulatory@aabb.org.