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After conducting a thorough review of its review functions and organizational structure, and evaluating a variety of alternatives that would allow the center to more efficiently accomplish its regulatory mission, FDA’s Center for Biologics Evaluation and Research (CBER) has undergone an internal restructuring. The new CBER structure includes the Office of Tissues and Advanced Therapies (OTAT) – formerly known as the Office of Cellular, Tissue and Gene Therapies, or OCTGT. The products regulated by OTAT will also include antivenins, and all purified and recombinant versions of therapeutic proteins for hematology.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
