FDA Center for Biologics Evaluation and Research

Company Overview
FDA’s Center for Biologics Evaluation and Research (CBER) regulates biological products. The mission of CBER is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, tissue, allergenics and biological therapeutics.

Quick Facts
FDA Center for Biologics Evaluation and Research
Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration
1401 Rockville Pike, Suite 200N
Rockville, MD 20852-1448

Web:	www.fda.gov/cber/
Email:	matt@cber.fda.gov

Phone:

1-888-INFO-FDA (1-888-463-6332)

Featured Solutions

• Guidance for Industry: Characterization and qualification of cell substrates ... by FDA Center for Biologics Evaluation and Research
  This draft guidance issued by the U.S. FDA on Sept. 28, 2006 conveys information for determining the suitability of a cell culture for manufacturing, as well as testing and validating the safety and purity of the cells used in the development and production of viral vaccines.
  
  
• Guidance for Industry: Collection of Platelets by Automated Methods by FDA Center for Biologics Evaluation and Research
  This guidance provides revised recommendations for the collection of platelets by automated methods (plateletpheresis). This guidance is intended to help ensure donor safety and the safety, purity, and potency of platelets collected by an automated blood cell separator device.
  
  
• Vaccine Safety: An FDA Perspective by FDA Center for Biologics Evaluation and Research
  This paper by the FDA CBER describes the major components of FDA’s evaluation of a biologics license application for a preventive vaccine, discuss the sources of data that FDA uses to monitor vaccine safety after licensure, and describe interactions between FDA and other governmental agencies in vaccine safety and other vaccine-related activities.