FDA’s Center for Biologics Evaluation and Research (CBER) was created

In 1988 the Center for Biologics Evaluation and Research (CBER) was created within the FDA to regulate biological products, including blood, vaccines, tissue, allergenics, and biological therapeutics.

There was a merger of FDA Drug and Biologics departments on June 30, 2003 but vaccines and gene therapy products remained with CBER [1, 2]