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Transfer of Therapeutic Biological Products to the
Center for Drug Evaluation and Research

On June 30, 2003, FDA transferred some of the therapeutic biological products that had been reviewed and regulated by the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER). CDER now has regulatory responsibility, including premarket review and continuing oversight, over the transferred products. In regulating the products assigned to them, CBER and CDER will consult with each other regularly and whenever necessary.

On October 1, 2003, the staff comprising CBER’s Office of Therapeutics Research and Review also transferred to CDER. CDER created two new offices to accommodate the former CBER staff:

• the Office of Drug Evaluation VI, within CDER’s Office of New Drugs, and
• the Office of Biotechnology Products, within CDER’s Office of Pharmaceutical Science.

For further information about the organizational structure of the two new offices in CDER, see www.fda.gov/cder/biologics/default.htm.

The lists below identify categories of therapeutic biological products transferred from CBER to CDER, and categories of therapeutic biological products remaining in CBER. Please note that the CBER list contains only a portion of the products CBER currently regulates; this list contains products that are closely related in chemical structure to products that transferred to CDER, e.g. therapeutic proteins and polysaccharides. Products are included on the CBER list as a means of clarifying the products that transferred and those that did not.

Categories of Therapeutic Biological Products Transferred to CDER

• Monoclonal antibodies for in vivo use.
• Proteins intended for therapeutic use, including cytokines (e.g. interferons), enzymes (e.g. thrombolytics), and other novel proteins, except for those that are specifically assigned to CBER (e.g., vaccines and blood products). This category includes therapeutic proteins derived from plants, animals, or microorganisms, and recombinant versions of these products.
• Immunomodulators (non-vaccine and non-allergenic products intended to treat disease by inhibiting or modifying a pre-existing immune response).
• Growth factors, cytokines, and monoclonal antibodies intended to mobilize, stimulate, decrease or otherwise alter the production of hematopoietic cells in vivo. ¹

Categories of Therapeutic Biological Products Remaining in CBER

• Cellular products, including products composed of human, bacterial or animal cells (such as pancreatic islet cells for transplantation), or from physical parts of those cells (such as whole cells, cell fragments, or other components intended for use as preventative or therapeutic vaccines).
• Vaccines (products intended to induce or increase an antigen specific immune response for prophylactic or therapeutic immunization, regardless of the composition or method of manufacture).
• Allergenic extracts used for the diagnosis and treatment of allergic diseases and allergen patch tests.
• Antitoxins, antivenins, and venoms
• Blood, blood components, plasma derived products (for example, albumin, immunoglobulins, clotting factors, fibrin sealants, proteinase inhibitors), including recombinant and transgenic versions of plasma derivatives, (for example clotting factors), blood substitutes, plasma volume expanders, human or animal polyclonal antibody preparations including radiolabeled or conjugated forms, and certain fibrinolytics such as plasma-derived plasmin, and red cell reagents.

Combination Products

The lists above contain some combination products comprised of a biological product component with a device and/or drug component, though such products are not specifically identified. Combination products are assigned to a Center for review and regulation in accordance with the products’ primary mode of action.² When a product’s primary mode of action is attributable to a type of biological product assigned to CDER, the product will be assigned to CDER. Similarly, when a product’s primary mode of action is attributable to a type of biological product assigned to CBER, the product will be assigned to CBER. For further information about combination products, see www.fda.gov/oc/combination, or contact the Office of Combination Products at 301-427-1934, or combination@fda.gov.

Further Information

Questions about the assignment of specific products to CBER or CDER should be directed to the center jurisdiction officers at:

CDER Ombudsman ......................... 301-594-5480

CBER Ombudsman ......................... 301-827-0379

_______________________________________________

Footnotes

¹Growth factors, cytokines, and monoclonal antibodies intended to mobilize, stimulate, decrease or otherwise alter the production of hematopoietic cells in vivo, for the purpose of being harvested for use in the production of a therapeutic cellular or blood product, may be regulated in combination with the therapeutic cellular or blood product, as appropriate. Sponsors of products that fit this description should contact the center jurisdiction officers listed below for guidance on appropriate center assignment.

² See 21 U.S.C. § 353(g), section 503(g) of the Federal Food, Drug, and Cosmetic Act.

Office of Combination Products

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