Food and Drug Administration
Blood Products Advisory Committee
March 13-14, 2003
BRIEFING INFORMATION
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