The Challenge and Mission with Biologics
The mission of the FDA Center for Biologics Evaluation and Research (CBER) is to protect and enhance the public health through the regulation of biological and related products including blood and blood components, vaccines, allergenics, live biotherapeutic products, tissues, and cellular and gene therapies. CBER conducts critical review activities to ensure the safety, purity, potency, and effectiveness of products in its jurisdiction.
Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms) and are not easily identified or characterized. Many of these products are manufactured using biotechnology and they often represent cutting-edge biomedical research.
To help keep pace with rapidly evolving technical and scientific issues impacting biological products, and address challenges in the development and regulatory evaluation of these products, CBER also has an extensive mission-related intramural research program (additional information on CBER research topics and programs). In order to achieve the goal of advancing product development and informing the scientific basis for the regulation of biologics, CBER scientists conduct research into all of its product lines, including allergenics, blood, cellular and gene therapies, tissues, and vaccines. This includes developing improved methods and tools to evaluate the safety, effectiveness, consistency, and quality of increasingly complex and diverse products.