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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 Dr. Karen Midthun, M.D. 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). ==Scope== *Blood for transfusion and as a raw material for drug products, as well as reagents used for blood typing and other related activities. *Plasma derivatives, including immunoglobulins, hyperimmune products, and antitoxins. *Human cells, tissues, and cellular and tissue-based products (HCT/Ps), except vascularized organs for transplantation and the associated blood vessels. *Vaccines for use in humans. *Diagnostic and therapeutic allergenic extracts. *Live biotherapeutics (probiotics). *Some medical devices, specifically test kits for HIV, tests used to screen blood donations, blood bank collection machines and equipment, and blood bank computer software. *Xenotransplantation. *Gene therapy and Human Cloning.〔(CBER website, CBER's Vision and Mission ) Retrieved August 30, 2012.〕 *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. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Center for Biologics Evaluation and Research」の詳細全文を読む スポンサード リンク
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