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 the Therapeutic Biologic Applications (BLA) Web page.
Beginning October 4, 2004, all submissions for therapeutic biological products (EXCLUDING 21 CFR 600.80 postmarketing adverse experience reports; advertising and promotional labeling; and 21 CFR 600.14 biological product deviation reports) that have been transferred to CDER should be sent to:
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Therapeutic Biological Products Document Room
5901-B Ammendale Road
Beltsville, MD 20705-1266
All submissions for biological products that remain in CBER should continue to be sent to:
U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
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.
Product information for the product classes transferring to CDER have been relocated to CDER's Therapeutic Biologic Applications (BLA) Web page. A list of specific products that transferred to CDER is provided.
Product information for the product classes remaining in CBER will remain on the CBER web site.
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).
- Gene therapy products. Human gene therapy/gene transfer is the administration of nucleic acids, viruses, or genetically engineered microorganisms that mediate their effect by transcription and/or translation of the transferred genetic material, and/or by integrating into the host genome. Cells may be modified in these ways ex vivo for subsequent administration to the recipient, or altered in vivo by gene therapy products administered directly to the recipient.
- 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.
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, see the Combination Products Web page, or contact the Office of Combination Products at 301-827-9229,or firstname.lastname@example.org.
FEDERAL REGISTER: Drug and Biological Product Consolidation; Investigational New Drug Application Number Conversion (PDF - 48KB) - 11/17/2005
FEDERAL REGISTER Food and Drug Administration Regulations: Drug and Biological Product Consolidation; Addresses; Final Rule; Technical Amendment (PDF - 87.3KB) - 3/24/2005
FEDERAL REGISTER: Drug and Biological Product Consolidation (PDF 40.2KB) - 6/26/2003
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
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.
Therapeutic Biologics Applications (BLA)
Center for Drug Evaluation and Research
Letter to Sponsors - Transfer of Therapeutic Products to the Center for Drug Evaluation and Research Drug and Biological Product Consolidation; Investigational New Drug Application Number Conversion(PDF - 48KB) [ARCHIVED]
Federal Register (11/17/2005)
Drug and Biological Product Consolidation; Addresses; Final Rule; Technical Amendment(PDF - 87KB) [ARCHIVED]
Federal Register (3/24/2005)
Drug and Biological Product Consolidation(PDF - 40KB) [ARCHIVED]
Federal Register (6/26/2003)