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Regulatory Affairs

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This page includes information on federal regulations and recommendations, compliance issues, emerging risks, and donor and patient health and safety issues facing the transfusion medicine and cellular therapies communities. For more information and recent actions, select links to areas of interest below. In addition we recommend you refer to the Recent Actions and the AABB Quick Links for analyses and related resources that provide a more in-depth look at the subject matter and offer strategies for compliance.

AABB represents the interests of AABB members, donors, and patients in need of lifesaving blood and cellular therapy products through interactions with the FDA and other government agencies. The Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has regulatory oversight of the blood and blood components used for transfusion or for further manufacture of pharmaceuticals, such as clotting factors, and products standards; related products, such as cell separation devices and blood collection and storage containers; infectious disease tests that help protect the safety of the blood supply; and products and devices supporting activities in transfusion services.

CBER also has regulatory oversight of cellular therapy products. CBER’s authority to regulate these products follows several pathways, based on the product’s processing, intended use, country of collection and manufacture, as described in detail on the Cellular Therapies pages.

AABB monitors emerging issues and developments in federal regulatory activities to assist members with implementation and compliance strategies for regulations and recommendations. AABB and the member experts serving on AABB Committees work closely with the FDA, the Centers for Disease Control and Prevention, and others to identify and evaluate potential risks, to develop safety and technical standards, and monitor blood supplies in support of a safe and adequate supply of blood and blood products.

AABB also advocates on issues related to Billing and Reimbursement Initiatives.

General Biologics Information

Blood and Blood Components

Cellular Therapy