Food and Drug Administration
1401 Rockville Pike, Suite 200N
Rockville,
MD 20852-1448
800-835-4709 (Voice - Toll-free)
301-827-1800 (Voice)
The Center for Biologics Evaluation and Research (CBER) is a center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services. CBER's mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.
The Center distributes various publications, including guidelines and Points to Consider for clinical trials and manufacturing biologics.