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The FDA Center for Biologics Evaluation and Research (CBER) is the home of biologics regulation today. When DBS was administratively transferred from the NIH to the FDA, it was called the Bureau of Biologics. During the 1980s and 1990s there was significant organizational change in biologics at the FDA. In 1982, the Bureau of Biologics merged with the Bureau of Drugs to form the National Center for Drugs and Biologics (NCDB). In 1983, the biologics component was renamed the Office of Biologics Research and Review (OBRR) within the Center for Drugs and Biologics (CDB). In 1988 1987, more changes happened when the CDB separated into two centers: the Center for Biologics Evaluation and Research (CBER), which was formerly the OBRR, and the Center for Drug Evaluation and Research (CDER). CBER has remained the name for the biologics regulation team at the FDA ever since. In 2002, some functions of CBER were transferred to CDER, to allow CBER to focus on regulating vaccines, gene therapy, tissue transplantation, and blood safety. FDA’s review of new pharmaceutical products, which had been partially done by both CBER and CDER in the past, would be consolidated to CDER.

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