BLOOD PRODUCTS ADVISORY COMMITTEE

BLOOD PRODUCTS ADVISORY COMMITTEE

September 16-17, 1999

Briefing Information

COMMITTEE UPDATES

Summary of PHS Advisory Committee Meeting - Stephen Nightingale, MD, OASH, PHS, HHS

Summary of Workshop on Donor Suitability: Blood Donor Deferral for History of Hepatitis - Robin Biswas, MD, DTTD, OBRR, CBER, FDA

Summary of Guidance Document on Revised Precautionary Measures to Reduce the Possible Risk of Transmission of CJD and nvCJD by Blood and Blood Products - Mary Elizabeth Jacobs, PhD, OBRR, CBER, FDA

Update on Senv Virus - Edward Tabor, MD, OBRR, CBER, FDA

Update on Status of Blood Regulations - Martin Ruta, JD, PhD, OBRR, CBER, FDA

HCV Lookback - Paul Mied, PhD, DTTD, OBRR, CBER, FDA

Post-Donation Information Affecting Safety of Plasma Derivatives: Revised Algorithm - Edward Tabor, MD, OBRR, CBER, FDA

I

Strategies for Increasing the Blood Supply: Informational - Capt. Mary Gustafson, DBA, OBRR, CBER, FDA

II

Nucleic Acid Testing of Blood Donors for Human Parvovirus B-19 - Thomas Lynch, PhD

III

Antigen/Antibody Testing for Malaria Informational, Chiang Syin, PhD, DTTD, OBRR, CBER, FDA

IV

Medical Device Panel Reclassification of HIV Drug Sensitivity Assays -- Andrew Dayton, MD, PhD, Part I

Medical Device Panel Reclassification of HIV Drug Sensitivity Assays -- Andrew Dayton, MD, PhD, Part II

Haemonetics Corporation Presentation