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.
REGULATORY UPDATE: ‘Ask the FDA and CMS/CLIA 2024’ Annual Meeting Slides Now Available
November 20, 2024
REGULATORY UPDATE: FDA Issues Draft Guidance to Support CGT Development
November 19, 2024
FDA Approves Direct-to-Brain Gene Therapy for AADC Deficiency
November 14, 2024