FDA Presentations

• April 28-29, 2011: Blood Products Advisory Committee Meeting Presentation: Current Considerations on Plasma for Further Manufacturing Obtained from Whole Blood Donors (PPT - 285KB)
  Alan E. Williams, Ph.D.
• April 28-29, 2011: Blood Products Advisory Committee Meeting Presentation: Blood Donor Written Statement of Understanding Introduction (PPT - 1.1MB)
  Orieji Illoh, MD
• April 28-29, 2011: Blood Products Advisory Committee Meeting Presentation: Blood Donor Written Statement of Understanding Questions for the Committee (PPT - 183KB)
• April 28-29, 2011: Blood Products Advisory Committee Meeting Presentation: FDA/PPTA Workshop: Risk Mitigation Strategies to Address Procoagulant Activity in Immune Globulin Products (PPT - 81KB)
  Dorothy Scott, M.D., Mikhail Ovanesov, Ph.D.
• April 28-29, 2011: Blood Products Advisory Committee Meeting Presentation: Proposed Workshop: Hemoglobin Standards and Maintenance of Iron Stores in Blood Donors (PPT - 83KB)
• April 28-29, 2011: Blood Products Advisory Committee Meeting Presentation: Concurrent and Component Plasma: CBER Considerations on Standards and Labeling (PPT - 1MB)
  Mark Weinstein, Ph.D.
• April 28-29, 2011: Blood Products Advisory Committee Meeting Presentation: Testing Source Plasma for Hepatitis B Virus by Nucleic Acid Testing (PPT - 416KB)
  Susan A. Zullo, Ph.D.

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• April 28-29, 2011: Blood Products Advisory Committee Meeting Presentation: Pooled HBV NAT Using the UltraQual™ HBV PCR Assay (PPTX - 17.7MB)
  Richard Smith, PhD
• April 28-29, 2011: Blood Products Advisory Committee Meeting Presentation: BioLife Plasma Services Experience with HBV NAT Testing (PPTX - 1.2MB)
  Gerold Zerlauth
• April 28-29, 2011: Blood Products Advisory Committee Meeting Presentation: Plasma Protein Therapies (PPT - 3.4MB)
  Douglas C. Lee, PhD
• April 28-29, 2011: Blood Products Advisory Committee Meeting Presentation: PPTA’s Voluntary Standards/HBV NAT Testing (PPTX - 1.1MB)
  Joshua Penrod
• April 28-29, 2011: Blood Products Advisory Committee Meeting Presentation: Quarantine Release Errors (QREs) (PPT - 90KB)
  Teresita C. Mercado
• April 28-29, 2011: Blood Products Advisory Committee Meeting Presentation: Donor’s Written Statement of Understanding (PPT - 1020KB)
  Beth H. Shaz, MD
• April 28-29, 2011: Blood Products Advisory Committee Meeting Presentation: Source Plasma Testing for HBV by NAT (PPT - 6MB)
  John Saldanha