About the Center for Biologics Evaluation and 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.
Key Resources
About CBER Meet Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research CBER Offices & Divisions Key Staff Directory, Organization Charts CBER Vision & Mission Biologics Research, Regulatory Information, Safety & Availability, Guidances, Development & Approval, Enforcement & Compliance International Activities PAHO/WHO Activities, Building Regulatory Capacity News & Events (Biologics) What's New, Meetings & Workshops CBER Reports CBER Annual Report, Performance, FDAMA, PDUFA, FDAAA, PREA Biologics Regulated Products Allergenics, Blood & Blood Products, Cellular & Gene Therapy Products, Tissue & Tissue Products, Vaccines, Xenotransplantation Contacts in the Center for Biologics Evaluation & Research (CBER) Consumer questions, manufacturer's assistance, media inquiries, technical questions, requesting speakers, establishment registration... Jobs at the Center for Biologics Evaluation and Research (CBER) Frequently Asked Questions about the Center for Biologics Evaluation and Research (CBER) and the Products CBER Regulates Biologics Electronic Reading Room (eFOI) Documents frequently requested through the Freedom of Information Act. What’s New for Biologics CBER Strategic Plan FY 2012-2016 (PDF - 226KB)Strategic Plan for Regulatory Science and Research 2012-2016 (PDF - 272KB)CBER HAS MOVED
