Gourt > Regional > North America > United States > Government > Executive Branch > Departments > Department of Health and Human Services > Food and Drug Administration > Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research (CBER) is one of five main centers for the Food and Drug Administration, which is in the United States Department of Health and Human Services. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biological products such as:
- Blood and blood products.
- Cells and tissues for transplant.
- Vaccines.
- Gene therapy.CBER websit, CBER's Vision and Mission: *
Authority
As of July 2006 CBER's authority resides in section 351 of the Public Health Service Act and in various sections of the Food, Drug and Cosmetic Act.CBER website, About CBER:* More on [ Center for Biologics Evaluation and Research ]
Next speaker: Hana Golding, MD, Chief, Laboratory of Retrovirus Research, Center for Biologics Evaluation and Research (CBER) #fdasws
drval (drval) Wed, 04 Nov 2009 14:31:24 -0000
Next speaker: Hana Golding, MD, Chief, Laboratory of Retrovirus Research, Center for Biologics Evaluation and Research (CBER) #fdasws
Research (CBER) - Protects and enhances the public health through regulation of biological products including blood, vaccines, therapeutics and related drugs and devices according to statutory authorities
Meta Description: [ CBER Center for Biologics Evaluation and Research, FDA ]
Allergenics - Regulates allergenic products. Site links to Advisory Committee meeting schedule and allergenics policy guides.
Meta Description: [ CBER Allergenics ]
Blood - The FDA is responsible for ensuring the safety of our nation's blood supply. The CBER regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes standards for the products themselves.
Meta Description: [ CBER Blood ]
Devices - The CBER regulates the medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products. CBER also regulates all HIV test kits.
Meta Description: [ CBER Devices ]
Electronic Freedom of Information Act Reading Room (EFOIA) - Provides access to all the documents posted on the CBER website. These documents are ones frequently requested by the public through the Freedom of Information Act.
Meta Description: [ CBER - Reading Room (EFOIA) ]
Licensed Product Information - Alphabetical list by the proper name of the product. Links to the approval letter, label and review documents files for each product.
Meta Description: [ CBER Licensed Product Approval Information ]
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Therapeutics - The Center regulates a variety of biological therapeutic products, as diverse as blood and blood components; antitoxins; proteins generated by hybridoma or recombinant DNA technology; products that consist of manipulated, cultured, or expanded human cells; vaccines directed against non-infectious disease targets; and gene transfer products.
Meta Description: [ 404 Message--Page Not Found ]
Tissue - The CBER currently regulates human tissue intended for transplantation. Examples of such tissues are bone, skin, corneas, ligament and tendon.
Meta Description: [ CBER Tissue ]
Vaccines - The Center regulates vaccine products. Vaccines undergo a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency of these products. Major sections are Flu Vaccine, Thimerosal, Anthrax, and Bovine Spongiform Encephalopathy, (mad cow disease.
Meta Description: [ CBER Vaccines ]
