FDA-Center for Biologics Evaluation and Research
The Center for Biologics Evaluation & Research (CBER) within the Food & Drug Administration (FDA) regulates biological products for human use under applicable federal laws. CBER protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. CBER's Office of Tissues and Advanced Therapies (OTAT) plans and conducts research related to the development, manufacture, and testing of cellular, tissue, gene therapy products, and plasma protein biologics and recombinant analogues.