REGULATORY UPDATE: FDA Revises 2024 Guidance Agenda

July 16, 2024

In last week's Weekly Report, AABB described that the Food and Drug Administration removed the proposed draft guidance, “Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),” from the “Therapeutic Products” category. In yesterday’s guidance agenda update, FDA has reincluded that guidance.

Members with questions may contact regulatory@aabb.org