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The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.
As part of the US Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. The Center is a consumer watchdog in Americas healthcare system.
CBER regulates medical devices related to licensed blood and cellular products by applying appropriate medical device laws and regulations.
CBERs 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.
CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act.

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Overview: CBER Regulated Products Biological products, including blood and blood products, vaccines, allergenics, gene therapies and xenotransplantation.
FDA Organization Charts FDA Overview Chart, including the Office of the Commissioner and FDA HQ offices. Center for Biologics Evaluation and Research. Center for Devices and Radiological Health. Center for Drug Evaluation and Research. Center for Food Safety and Applied Nutrition. Center for Tobacco Products.
Historically, CBER was responsible for some therapeutic proteins, such as monoclonal antibodies. Control of these has been transferred to CDER. Some other drugs, such as certain anticoagulants and plasma volume expanders remain under the control of CBER.

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