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  1. Cellular & Gene Therapy Products

Establishment of the Office of Therapeutic Products

The mission of the Center for Biologics Evaluation and Research (CBER) is to protect and enhance public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. CBER is making changes to its organizational structure in order to address the substantial growth in the development of innovative, novel products and the ever-changing public health landscape.

In order to meet these challenges head on, CBER has established the new Office of Therapeutic Products (OTP). This new super office is the result of a reorganization of the Center’s Office of Tissues and Advanced Therapies and includes six new offices within the super office structure. This reorganization creates flexibility and capacity for future growth in the number of Full-Time Employee (FTE) positions as CBER works to meet the commitments and hiring goals outlined in the Prescription Drug User Fee Agreement (PDUFA) for fiscal years 2023-2027. The structural changes improve discipline alignment, increase review capacity, and enhance expertise in cell and gene therapies. Additional review staff and supervisory positions will not only help to address the increased workload but will also enhance the timeliness and consistency of the office’s interactions with sponsors and provide advancement opportunities to facilitate recruitment and retention of highly qualified staff.


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