FDA Center for Biologics Evaluation & Research (CBER)
CBER is the Center within FDA that 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.
To ensure the safety, purity, potency, and effectiveness of biological products including vaccines, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, or injury. Through our mission, we also help to defend the public against the threats of emerging infectious diseases and bioterrorism.
In fulfilling our mission as a Center in the U.S. Food and Drug Administration, we apply the following principles with the highest ethical standards and integrity:
Develop, maintain, and support a high-quality and diverse workforce;
Ensure compliance with laws and regulations through review, education, surveillance, and enforcement; and
Conduct research as an essential element of science-based decision-making.