Food & Drug Administration (US)

• FDA Center for Biologics Evaluation and Research

The Center for Biologics Evaluation and Research (CBER) is one 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. Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms), are not easily identified or characterized, and many are manufactured using biotechnology. These products often represent cutting-edge biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have few or no other treatment options.

Guidances

• Frequently Asked Questions About Therapeutic Biological Products

A comprehensive look at how CBER works answering questions from what CBER is, the products it regulates, CBER's role post-approval to import/export rules relating to biologics and how to find further information about ongoing clinical trials, and other regulatory bodies.