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Center for Biologics Evaluation and Research (CBER)

What is the Center for Biologics Evaluation and Research (CBER)?

The CBER regulates biological products for human use under the Federal Food, Drug, and Cosmetic Act, Public Health Service Act, and other federal laws. The CBER is a part of the U.S. Food and Drug Administration (FDA).

Biological products evaluated by the CBER include:

While most biologics are regulated by the CBER, therapeutic proteins, monoclonal antibodies, and immunomodulators fall under the Center for Drug Evaluation and Research’s (CDER’s) regulation.

The CBER evaluates biological products by reviewing the scientific and clinical data submitted by manufacturers to determine if the product meets the CBER’s standards for approval, namely if its benefits outweigh its potential risks, but also if it is labeled correctly with all the necessary information.

What role does the CBER play in improving healthcare?

The CBER protects and advances the public’s health by ensuring that any marketed biological products are safe, effective, and available to those who need them. The CBER is also responsible for ensuring that the public has enough information on biological products to use them safely and appropriately.