Food and Drug Administration

Blood Products Advisory Committee

March 13-14, 2003


Committee Updates

Medical Device User Fee and Modernization Act (MDUFMA) - Mary Elizabeth Jacobs, PhD, CBER  ppt  htm

CLIA Waiver for the OraQuick® Rapid HIV-1 Antibody Test, Elliot P. Cowan, Ph.D., CBER   ppt   htm

Monitoring Blood Supply Shortages The TRANS-Net Pilot, Alan E. Williams, Ph.D., CBER   ppt   htm

I.  West Nile Virus (WNV) Testing

Topic: Validation of nucleic acid tests (NAT) to screen blood and plasma donors for acute infection with West Nile virus (WNV)  pdf  htm Word

Validation of Nucleic Acid and Serological Tests to Screen Blood and Plasma donors for Acute infection with West Nile virus, Hira Nakhasi, Ph.D., CBER   ppt   htm

TMA Assay for Detection of West Nile Virus, Cristina Giachetti, Ph.D., J. Linnen; A. Broulik; W. Wu; J. Cline; M. Lewis; G. Dennis; M. Cass; M. Alden; V. Casas; and S. Miller, Gen-Probe Incorporated   ppt   htm

Development of a Supplemental WNV Taqman Assay and Other Critical Reagents in Support of the Procleix WNV Assay, Bruce Phelps, Chiron Corporation   ppt   htm

West Nile Virus, Update on Assay Development, George J. Dawson, Ph.D., Abbott Laboratories  ppt   htm

Approval Criteria for Assays for Testing Blood Donors for West Nile Virus, Robin Biswas, M.D., CBER  ppt  htm

Topic I: List of Reprints  pdf   htm  Word

West Nile Virus, Dominique Pifat, Ph.D., Bayer Biological Products on behalf of PPTA Viral Safety Working Group   ppt   htm

Statement of American Association of Blood Banks, America's Blood Centers, American Red Cross, Roger Y. Dodd, Ph.D.   pdf   htm  Word

II.  Discussion on Extension of the Storage Period for Pooled Platelets

Summary for Topic II: Discussion on Extension of the storage period for pooled platelets   pdf   htm   Word

Bacterial Detection in Platelet Products, Mark E. Brecher  ppt   htm

European Experience with Extended Storage of Platelet Pools, Ruby N.I. Pietersz, M.D., Ph.D.  pdf   htm  Word

Topic II: List of Reprints  htm  Word  pdf

Statement of The American Association of Blood Banks, Kay R. Gregory, MS, MT(ASCP)SBB  pdf   htm  Word

Committee Update on Particulates in Blood Bags

Frequently Asked Questions on FDA's Continuing Investigation of Particulate Matter in Blood

Information Alert on Particulate Matter in Blood Bags