What Center has the regulatory responsibility for therapeutic biological products?
Both the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, including premarket review and oversight. The categories of therapeutic biological products regulated by CDER (under the FDC Act and/or the PHS Act, as appropriate) are the following • Monoclonal antibodies for in vivo use. • Most 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 the Center for Biologics Evaluation and Research (CBER) (e.g., vaccines and blood products). This category includes therapeutic proteins derived from plants, animals, humans, or microorganisms, and recombinant versions of these products. Exceptions to this rule are coagulation factors (both recombinant and human-plasma derived). • Immunomodulators (non-vaccine and non-allergenic products inten
