Jurisdictional Update: Drug-Biologic Combination Products
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. More information about the transfer is available on the Jurisdictional Transfers section of the FDA website.
Combination products are assigned to a Center for review and regulation in accordance with the products’ primary mode of action. When a combination product’s primary mode of action is attributable to a type of biological product assigned to CBER, the product will be assigned to CBER. Similarly, when a combination product’s primary mode of action is attributable to a type of biological product assigned to CDER, the product will be assigned to CDER. For drug-biologic combination products where both the drug and biological product components are regulated by CDER, the combination product will be assigned to CDER.
FDA has received several inquiries regarding the most appropriate procedures to follow in determining the lead CDER reviewing division for drug-biologic combination products where both the drug and biological product components of the combination product are regulated by CDER. FDA recommends that questions about the assignment of a drug-biologic combination product to a reviewing division within CDER be initially directed to CDER’s Ombudsman at 301-796-3436. Alternately, in accordance with 21 CFR Part 3, sponsors may submit a Request for Designation (RFD) for such products. More information on the RFD process is available on the RFD Process section of the FDA website.