FDA's Center for Biologics Evaluation and Research (CBER) regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.
CBER incorporates advances in science and technology into the full product life cycle from concept to marketed product. This focus on integration facilitates access to safe and effective products that improve how patients feel, function, and survive. The development of innovative products presents unique challenges, and CBER must balance timely patient access to novel (new) products with meeting key standards for safety and efficacy, such as the current Good Manufacturing Practice (cGMP) regulations for human pharmaceuticals.
Goal 1: Facilitate the Development and Availability of Safe and Effective Medical Products Through the Integration of Advances in Science and Technology
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons.