Regulatory Affairs

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.

Regulatory Resources

Up-to-date resources and practical tools, including the 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.

Government Advisory & Regulatory Meetings

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.

AABB Regulatory Affairs Staff

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