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7.2: The Center for Biologics, Evaluation, and Research

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  • CBER Offices and Divisions

    The Center for Biologics, Evaluation & Research (CBER) is the primary Center in the FDA, which oversees the regulation of biologic & related products. We will explore in this chapter the broad range of biological products CBER reviews. There are three main review offices in CBER; Office of Blood Research and Review (OBRR); Office of Cellular, Tissue and Gene Therapies (OCTGT); and the Office of Vaccine Research and Review (OVRR).

    It is important to note here that CBER does oversee medical devices that are associated with the collection and testing of licensed blood and cellular products. CBER states its mission “To ensure the safety, purity, potency, and effectiveness of biological products including vaccines, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, or injury. Through our mission, we also help to defend the public against the threats of emerging infectious diseases and bioterrorism.” (FDA, 2016)

    Biologics Product Categories

    1. Allergenics are allergen extracts, allergen patch tests, and antigen skin tests
    2. Blood & Blood Products Blood, Blood Components, Blood Bank Devices, Blood Donor Screening Tests
    3. Cellular & Gene Therapy Products Gene-based Treatments, Cell-based Treatments, Cloning
    4. Tissue & Tissue Products Bone, Skin, Corneas, Ligaments, Tendons, Stem Cells, Sperm, Heart Valves
    5. Vaccines for Use in Children and Adults, Tuberculin Testing
    6. Xenotransplantation Transplantation of Non-Human Cells, Tissues or Organs into a Human


    "Allergen extracts are used for the diagnosis and treatment of allergic diseases. This may include general seasonal allergies such as hay fever, or more severe allergies such as bee venom or food allergy. Currently, there are two types of licensed allergen extracts; injectable extracts and sublingual extract tablets. You are probably most familiar with injectable allergen extracts that are used for both diagnosing allergies as well as treating them. These extracts are manufactured from natural substances such as insect venom, animal hair protein, and pollens. Sublingual allergen extract tables are used for treatment only of allergic reactions. Allergen Patch tests are diagnostic tests applied to the surface of the skin by healthcare providers to determine the cause of contact dermatitis. Antigen skin tests are diagnostic tests injected into the skin to aid in the diagnosis of infection with certain pathogens" (

    Blood & Blood Products

    "CBER regulates the collection of blood and blood components used for transfusion or the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes standards for the products themselves. CBER also regulates related products such as cell separation devices, blood collection containers, and HIV screening tests that are used to prepare blood products or to ensure the safety of the blood supply. CBER develops and enforces quality standards, inspects blood establishments, and monitors reports of errors, accidents, and adverse clinical events" (

    Cellular & Gene Therapy Products

    "CBER regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. Cellular therapy products include cellular immunotherapies, which includes both adult and embryonic stem cells. Human gene therapy refers to products that introduce genetic material into a person’s DNA to replace faulty or missing genetic material, thus treating a disease or abnormal medical condition. Although some cellular therapy products have been approved, CBER has not yet approved any human gene therapy product for sale" (


    To learn more about how the FDA regulates Gene Therapy products, watch the following video.

    What regulations must companies follow for Gene Therapy products?

    Tissue & Tissue Products

    "Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product under 21 CFR Parts 1270 and 1271. Parts 1270 and 1271 require tissue establishments to screen and test donors, to prepare and follow written procedures for the prevention of the spread of communicable disease, and to maintain records. FDA has published three final rules to prevent the introduction, transmission, and spread of communicable disease; one final rule requires firms to register and list their HCT/Ps with FDA; the second rule requires tissue establishments to evaluate donors for infectious diseases; and the third final rule establishes current good tissue practices for HCT/Ps. It's important to note here that CBER does not regulate the transplantation of human organ transplants such as liver, kidney, or heart" (


    "Vaccines, as with all products regulated by FDA, undergo a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity, and potency of these products. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine's safety, effectiveness, or possible side effects. According to the Centers for Disease Control and Prevention, vaccines have reduced preventable infectious diseases to an all-time low, and now few people experience the devastating effects of measles, pertussis, and other illnesses. Many of these are childhood vaccines that have contributed to a significant reduction of vaccine-preventable diseases" (


    According to the FDA, xenotransplantation is “any procedure that involves the transplantation, implantation or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs” ( Organ transplant needs currently outpaces the supply, with over ten patients die each day waiting for an organ transplant, and xenotransplantation is one viable option.