The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) recently conducted a thorough review of its review functions and organizational structure. Senior Center leadership evaluated a variety of alternatives that would allow the Center to more efficiently accomplish its regulatory mission.
Based on this review, and in consultation with FDA leadership, CBER has undergone an internal restructuring. The new CBER structure includes the Office of Blood Research and Review (OBRR), the Office of Vaccines Research and Review (OVRR), and the Office of Tissues and Advanced Therapies (OTAT, formerly known as the Office of Cellular, Tissue and Gene Therapies, or OCTGT). The formation of OTAT involves the transfer of OBRR’s Division of Hematology Clinical Review and Division of Hematology Research and Review, along with appropriate support staff, to OCTGT to constitute the new office. The products now regulated by OTAT include all purified and recombinant versions of therapeutic proteins for hematology. Antivenins have also been transferred to OTAT.
This new organizational structure became effective on October 16, 2016. This restructuring should not have a significant impact on the review of pending applications, and CBER anticipates meeting its user fee obligations, including performance goals, during this transition.