The Center for Biologics Evaluation and Research (CBER) is the center within the U.S. Food and Drug Administration that regulates biological products, including blood components and cellular therapies. This session will introduce attendees to CBER and the multi-disciplinary workforce needed to accomplish its regulatory and public health mission. Presenters will describe the different roles and missions of the Office of Blood Research and Review (OBRR) and the Office of Tissues and Advanced Therapies (OTAT), highlighting some specific regulatory review and policy activities, and outlining some of their scientific research programs. The session will conclude with an overview of the product lifecycle, using examples to help attendees understand how a biologic or device makes its way to clinical use.
Explain the role of the Center for Biologics Evaluation and Research, the Office of Blood Research and Review, and the Office of Tissues and Advanced Therapies in regulating the products relevant to the transfusion medicine and cellular therapy communities.
Identify the professional disciplines involved in regulatory review.
Describe the regulatory pathways for biologics and devices and recognize how products commonly used in transfusion practice find their way through trials and to clinical use.