AABB is the voice of the blood and cellular therapies community before the Food and Drug Administration and FDA advisory committees, such as the Blood Products Advisory Committee and Cellular, Tissue, and Gene Therapies Advisory Committee. The Association engages stakeholders within AABB's membership and the broader community to develop materials that provide FDA with the community’s position on draft guidances, proposed regulations and policies, and research priorities. These AABB-led efforts create an important dialogue with federal regulators that helps promote a strong and safe supply of blood and cells.
CBER Releases Updated RMAT Designation Requests, Approvals and Withdrawals
February 12, 2025
REGULATORY UPDATE: Blood Community Submits Comments on HCT/P Draft Guidances
February 05, 2025
REGULATORY UPDATE: FDA Extends Implementation Date for Two HCT/P Guidances
February 03, 2025