AABB represents the interests of AABB members, donors, and patients in need of lifesaving blood and biotherapies products by monitoring emerging issues, engaging the Food and Drug Administration, and the Centers for Disease Control and Prevention regarding new information and data, and by providing formal comments to FDA during development of regulations and recommendations. AABB monitors the landscape of federal regulatory activities to assist members with implementation and compliance strategies for new regulations and recommendations.
Information on blood donor safety, screening and testing, whole blood and red blood cells, platelets, plasma, labeling and irradiation.
Up-to-date resources and practical tools, including the COVID-19 Resources for Blood Donor Centers, Donor History Questionnaires, the Circular of Information for Blood, “Ask the FDA and CLIA,” formal comments and statements to FDA and regulatory toolkits to assist with new requirements.
Information on transfusion-transmitted infections, emerging infectious diseases, and the SARS-CoV-2/COVID-19 pandemic.
Meeting and workshops with the federal government, including the Blood Products Advisory Committee (BPAC), the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC), and FDA Liaison Committee meetings.
Information on human cells, tissues, and cellular and tissue-based products (HCT/Ps), biological products and investigational cellular therapies. AABB also monitors information from international competent authorities.
SHARON CARAYIANNIS, MT(ASCP)HP
Senior Director, Regulatory Affairs
scarayiannis@aabb.org
301.215.6542
KAREN PALMER, MT(ASCP) CQA(ASQ)
Deputy Director, Regulatory Affairs
kpalmer@aabb.org
301.215.6514