BLOOD PRODUCTS ADVISORY COMMITTEE

September 15, 2000

Briefing Information

Workshop Summary: Recruiting Blood Donors - Successful practices, July 6-7, 2000 - Gilliam Conley doc

"Quick Summary" of the Joint Meeting of the Transmissible Spongiform Encephalopathies Advisory Committee, Vaccines and Related Biological Products Advisory Committee, July 27, 2000 doc

III. CURRENT UTILITY OF SCREENING BLOOD DONORS FOR ANTIBODIES TO SYPHILIS

Current Utility of Screening Blood Donors for Antibodies to Syphilis, The FDA Framework, Chiang Syin, Ph.D. htm

Syphilis: Overview of Clinical Features and Recent Epidemiology in the United States

Prevalence of circulating T. pallidum DNA and RNA in PK™TP+/ FTAșABS + blood donors

Relationship of anti-HIBc and Serologic Tests for Syphilis (STS) to Blood Donor Behavioral Risk factors, AE Williams, K Watanabe, DI Ameti, S Kleinman, M P Busch, S Orton, GJ Nemo htm

Amplification of DNA Polymerase I gene of T. pallidum from whole blood of persons with syphilis, Lauri Markowitz, MD, CDC

Early Cases of Syphilis Identified through Attempted Blood Bank Donation and Estimate of Risk, Lauri Markowtiz, MD, CDC

CDC's plan of Syphilis transfusion studies to adress the discrepancies between their studies and those conducted by American Red Cross doc

Questions for the Committee, Martin Ruta, J.D., Ph.D.

IV. CLASSIFICATION OF HLA DEVICES

Classification of HLA Devices - contents

Classification of HLA Devices, FDA Introduction & Background, Sheryl A Kochman ppt htm

Classification of HLA Devices

FDA's 510(k) Third-Party Review Program, Eric J. Rechen, FDA ppt htm

Disclaimer

The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

HLA-A Moving Target, Pel-Freez Clinical Systems LLC ppt htm

Classification of HLA Devices FDA Recommendations & Questions, Sheryl A Kochman ppt htm

Bibliography doc pdf