More Information on The Center For Biologics Evaluation and Research

FDA's Center for Biologics Evaluation and Research regulates the following products:  allergenic extracts, monoclonal antibodies, biotech derived therapeutics, somatic cell and gene therapy, xenotransplantation, tissues, some devices, whole blood, blood components, blood derivatives, and vaccines.

About CBER

CBER Fact Sheet [HTML] [PDF]

CBER's Frequently Asked Questions

CBER Manufacturers' Assistance Site

Commemorating 100 Years of Biologics Regulation

Organizational Chart PDF

CBER Vision 2004

Action Plans

• Blood
• Device
• Tissue
• Xenotransplantation 

CBER's Industry Assistance Information

Issues Concerning Blood and Biotechnology

A New Kind of Fish Story: The Coming of Biotech Animals

West Nile Virus

Testimony of Jesse Goodman, M.D., MPH, Director, Deputy Director of the Center for Biologics Evaluation and Research, to discuss FDA's response to the emerging threat of transmission of West Nile virus (WNV) through blood and tissue. (September 24, 2002)

Devices Regulated by CBER