Center for Biologics Evaluation and Research

CBER's past names

1880 —

–

1890 —

–

1900 —

–

1910 —

–

1920 —

–

1930 —

–

1940 —

–

1950 —

–

1960 —

–

1970 —

–

1980 —

–

1990 —

–

2000 —

–

2010 —

Renamed Hygienic Laboratory

Became part of the newly formed Public Health and Marine Hospital Service

Division of Biologics Control formed within NIH

Renamed Laboratory of Biologics Control

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).

^ McDonald, Sharon. (September 2002) "Science and the Regulation of Biological Products: From a Rich History to a Challenging Future." Center for Biologics Evaluation and Research.