Center for Biologics Evaluation and Research
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. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biological and related products, including:
- Blood for transfusion and as a raw material for drug products, as well as reagents used for blood typing and other related activities.
- 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.
- Allergenic extracts.
- 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.[1]
- Historically, CBER was responsible for some medications, such as antisera and antitoxins. Control of some of these has been transferred to CDER. Some other drugs, such as certain anticoagulants and plasma volume expanders remain under the control of CBER.
Authority
As of July 2006 CBER's authority resides in sections 351 and 361 of the Public Health Service Act and in various sections of the Food, Drug and Cosmetic Act.[2]
Section 351 of the Public Health Service Act requires licensure of biological products that travel in interstate commerce in the United States. CBER may deny licensure or suspend or cancel a current license if a manufacturer does not comply with requirements. Unlicensed blood products used within the boundaries of a state are not unusual, and these products are subject to general regulations from other FDA legal authorities.
Section 361 of the same act allows the Surgeon General to make and enforce regulations to control the interstate spread of communicable disease. This broad authority has been delegated to the FDA through a Memorandum of Understanding. Many of the products overseen by CBER are also considered drugs, and are subject to the same rules and regulations as any other drug product from the Food, Drug, and Cosmetic Act.
From these legal authorities, CBER publishes regulations which are included in the first chapter title 21 of the Code of Federal Regulations. Most of the regulations specific to CBER are found from 21CFR600-680. 21CFR1271 contains the rules for HCT/Ps. For products which are also drugs, such as blood for transfusion, rules in 21CFR200 and following apply. Other general rules, such as the regulations for clinical trials involving human subjects in 21CFR50, may also apply.
In addition to these laws and guidances, CBER also publishes guidance documents. These are not requirements, but are generally followed by industry. Licensed manufacturers are expected to adopt either the guidance or an equivalent process. In some cases, the guidance documents have the force of regulation because they are written to clarify existing rules.
Flu vaccines
CBER's Vaccines and Related Biological Products Advisory Committee meets annually for a discussion and vote concerning the next year's influenza vaccine virus selection.[3]
Further reading
References
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- ↑ CBER website, About CBER
- ↑ (transcript of U.S. FDA Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee's 101st meeting of February 16, 2005 is here: origin.www.fda.gov in .DOC format in Google provided HTML format)
