Science & Research (Biologics)
Research and Regulation at CBER
Welcome to the Center for Biologics Evaluation and Research (CBER) where we live up to our name: we evaluate biologic products in the U.S., and yes, we do research! A wide range of medicines are included in the category “biologic products.” These comprise a complex and diverse group of products, not easily produced by chemical synthesis and usually produced using biological systems. CBER regulates vaccines to prevent infectious diseases; vaccines used to treat conditions such as cancer; blood given in transfusions, products made from blood and from plasma, and blood donor screening assays; HIV diagnostics; allergenics; live biotherapeutics (such as some probiotics); and the rapidly growing group of cell therapies, gene therapies, and tissue therapies, including xenotransplantation. Laboratories at CBER also support work in the Office of Compliance and Biologics Quality, who test biological products to ensure their quality. CBER research creates knowledge to understand the effectiveness and safety of all of these products, helping to make them available as soon as possible.
Regulation of Biological Products by CBER Researcher-Reviewers
For over 75 years, the “researcher-reviewer” model has been a foundation of how CBER does business. CBER research scientists have a foot in each of two complementary worlds, with both research and regulatory responsibilities: CBER research generates new knowledge about biological products, and the same CBER investigators are product reviewers for CBER’s regulatory submissions. As product reviewers, CBER scientists critique all the details about how a new medical product is made and tested for quality. Conducting “chemistry, manufacturing, and control” (CMC) review gives CBER scientists a bird’s-eye view of many issues with novel products – and some of those issues become fuel for CBER research.
The science that underpins the safety, potency, and efficacy of new biological products is constantly evolving, and by conducting research, so are CBER’s researcher-reviewers. CBER scientists are on top of new developments in all the relevant biological disciplines and are intimately familiar with important technologies. The combination of research and regulatory expertise enables CBER scientists to tackle product development roadblocks in the lab, design important new approaches and tools to speed up product development, review product submissions very efficiently and effectively, make regulatory decisions informed by state-of-the-art science, and develop sound evidence-based policy.
