CBER's past names | ||
1880 — – 1890 — – 1900 — – 1910 — – 1920 — – 1930 — – 1940 — – 1950 — – 1960 — – 1970 — – 1980 — – 1990 — – 2000 — – 2010 — | Laboratory of Hygiene founded Renamed Hygienic Laboratory Became part of the newly formed Public Health and Marine Hospital Service Renamed National Institute of Health (NIH) Division of Biologics Control formed within NIH Renamed Laboratory of Biologics Control Incorporated into National Microbiological Institute (NIH) Renamed Division of Biologics Standards Transferred to the FDA; renamed Bureau of Biologics Merged to form Center for Drugs and Biologics Split to form the Center for Biologics Evaluation and Research | |
The present center can trace its history back to the original American public health service, which later became the NIH.[1] | ||
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products (such as vaccines, live biotherapeutics (probiotics), blood products, and cell, tissue, and gene therapies). Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER).