Center for Biologics Evaluation and Research (CBER) - FY 2007 Annual Report

In October, CBER published its annual report, which offers both a summary of CBER's tasks and visions and an overview of product innovations and new technologies, quality and availability of biological products, activities for the protection of public health and on patient and consumer safety for the fields:

• Blood and blood products
• Vaccines
• Cellular and gene therapies
• Tissues and tissue preparations
• Xenotransplantation
• Devices
• Allergenics

An interesting example from the field of product innovations is approval of a rapid test for detecting bacterial contamination in blood platelets, which CBER cleared for marketing in September 2007. This disposable test intended for the use in hospitals serves as a supplement to the existing quality assurance tests.

Furthermore, the annual report shows the current projects of the "Blood Safety Team" and  the "Tissue Safety Team" and lists the corresponding current guidelines and recommendations.

More information on CBER's FY 2007 Annual Report can be found here.

Author
Axel Schroeder
On behalf of the European Compliance Academy (ECA)