Food and Drug Administration

Blood Products Advisory Committee

June 19-20, 2003

Briefing Information

Medical Device User Fee and Modernization Act, Dr. Mary Jacobs, Ph.D. (HTM) (PPT)

FDA Update: Particulate Matter Task Force, Dr. Sharyn Orton, PhD. (HTM) (PPT)

Bovine Spongiform Encephalopathy (BSE) in Canada, Dr. Pedro Piccardo, MD (HTM) (PPT)

Current Status of Issues Related to West Nile virus testing and donor screening, Dr. Hira Nakhasi, Ph.D. (HTM) (PPT)

Update on status of West Nile virus test, lot release and validation panel development, Dr. Indira Hewlett, Ph.D (HTM) (PPT)

Revised Recommendations for the Assessment of Donor Suitability: West Nile Virus, Dr. Sharyn Orton, Ph.D (HTM) (PPT)

Recovered Plasma Comparisons, Elizabeth Callaghan, FDA (HTM) (PDF) (Word)

Recovered Plasma, Elizabeth Callaghan, FDA (HTM) (PPT)

Recovered Plasma Comparisons - Revised (HTM) (PDF) (Word)

Open Public Hearing

Plasma for Manufacture, AABB Task Force on Recovered Plasma, Kay Gregory, MS (HTM) (PPT)

TaqScreen West Nile Virus Program - Roche Update, Dr. James L. Gallarda, Ph.D (HTM) (PPT)