CBER is responsible for ensuring the safety and efficacy of blood and blood products, vaccines, allergenics, and biological therapeutics. CBER's regulation of biological products has expanded in recent years to include a wide variety of new products such as biotechnology products, somatic cell therapy and gene therapy, and banked human tissues.
If you have questions or are unable to find the information you need, please contact:
Center for Biologics Evaluation and Research
Office of Communication, Training & Manufacturers Assistance
800-835-4709 or 301-827-1800
octma@cber.fda.gov
Transfer of Therapeutic Products to CDER
FDA Advances Consumer Health and Safety in 2003
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