The Center for Biologics Evaluation and Research (CBER) conducts active mission-related regulatory science research programs in order to provide effective regulatory review of biological products. This research greatly expands our knowledge of fundamental biological processes and provides a strong scientific base for regulatory review.

The following provides information on regulatory science research programs in nanotechnology being conducted at CBER.

• Novel detection technologies for pathogen detection
  

  The goals of our work are to: 1) develop new, improved diagnostic tools for testing blood and plasma and rapidly detecting emerging pathogens that threaten public health; and 2) provide FDA product reviewers with improved scientific understanding of novel technologies, including those relying on use of nanomaterials, that might be applied by manufacturers, enhancing the review and evaluation of new diagnostic tests for blood-borne pathogens and bioterrorism agents. For more information, see: Improving Safety of the Blood Supply from Transmission of HIV/AIDS and Other Emerging Blood Borne Viral and Biodefense Agents by Developing Sensitive Diagnostic Tools and Investigating Disease Pathogenesis.

• Blood Safety
  

  The focus of this work is on the effects of various commercially-available carbon nanomaterials on blood cells and platelets and on vessel wall cells grown in tissue cultures. This research will help FDA to evaluate the safety and effectiveness of carbon nanomaterials in biomedical applications. For more information, see: Investigation of Potential Toxic Effects of Engineered Nanoparticles and Biologic Microparticles in Blood and Their Biomarker Applications.

   

For further information:

Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
Telephone: 1-800-835-4709
Email: [email protected]