The Center for Biologics Evaluation and Research (CBER) is a pivotal division of the U.S. Food and Drug Administration (FDA), established in 1902 following tragic incidents involving contaminated biological products. Originally part of the National Institutes of Health, CBER moved to the FDA in 1972 and has since become a global leader in regulating biologics—products derived from living sources such as humans, animals, and microorganisms. These include vaccines, blood and blood components, allergenics, cellular and gene therapies, tissues, and certain medical devices. CBER’s mission is to ensure the safety, purity, potency, and effectiveness of these advanced therapies, which often represent the cutting edge of biomedical innovation. The center evaluates scientific and clinical data submitted by manufacturers, making regulatory decisions based on a rigorous risk-benefit analysis. CBER also oversees the licensing and post-market surveillance of biologics, ensuring that products remain safe and effective throughout their lifecycle. A key aspect of CBER’s work is its role in facilitating the development and approval of novel technologies, including gene therapies and regenerative medicine products. The center is organized into specialized offices, such as those for vaccines, blood, and cellular therapies, and employs a cadre of scientific experts who bridge regulatory science and public health. CBER also collaborates with external advisory committees to seek expert input on complex scientific and technical issues. Today, CBER continues to shape the future of healthcare by advancing regulatory science, supporting innovation, and safeguarding public health. Its work is critical for companies in the biotech and pharmaceutical sectors, as it sets the standards for bringing life-saving biologics to market.