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This popular session consistently draws a large audience and provides an opportunity for the regulatory experts with the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services/Clinical Laboratory Improvement Amendments representatives to respond to member questions about new rules, regulations, and guidance. The session also allows the FDA to present their current thinking on policies, regulations, guidance documents, and inspection programs relevant to their oversight of blood and human cells, tissues, and tissue-based products (HCT/P) programs. Questions for the session are submitted in advance to regulatory@aabb.org.