Food and Drug Administration

Blood Products Advisory Committee

December 11-12, 2003

Briefing Information

Memorandumto AABB Members Regarding Deferral for Risk of Leishmaniasis Exposure(HTM) (PDF) (Word)

Abbreviated Flow Charts (HTM) (PDF) (Word)

Abbreviated Questionnaire (HTM) (PDF) (Word)

Abbreviated Issue Summary (HTM) (PDF) (Word)

Briefing Document (HTM) (PDF) (Word)

The Redesigned Donor History Questionnaire: The Abbreviated Donor Questionnaire Report of the Task Force to the FDA Blood Products Advisory Committee, Dr. Mary Townsend, MD (PPT)

Issue Summaru: Review of Plasma Collection Nomograms (HTM) (PDF) (Word)

Issue Summary: Potential Recommendation on Blood Donor Deferral for Leishmaniasis and Exposure to Lieshmania (HTM) (PDF) (Word)

MDUFMA Update, Dr. Mary Jacobs, PhD, FDA (PPT)

CBER ESM Registration Form (PDF)

Archives of Disease in Childhood, D Cummins, et.al. (PDF)

Blood Donor Education Material: Making Your Blood Donation Safe (HTM) (PDF) (Word)

ESM Instruction for Industry (PDF)

Full Length Questionnaire (HTM) (PDF) (Word)

Final Questionnaire- Highlighted (PDF)

Leishmaniasis, Barbara Herwaldt (PDF)

Visceral Infection Caused by Leishmania Trpoica in Veterans of Operation Desert Storm, Alan Magill, et.al. (HTM)

Medication List (HTM) (PDF) (Word)

Cutaneous Leishmaniasis in US Military Personnel--Southwest/Centrial Asia, 2002-2003 (HTM)

Reprints for Abbrevated History (HTM) (PDF) (Word)

Revisions to Labeling (HTM) (PPT)

Summary Material (HTM) (PDF) (Word)

UDHQTF Final Report to FDA (HTM) (PDF) (Word)

Update Detection of West Nile Virus in Blood Donations (HTM)

Donor History Questionnaire User Brochure (HTM) (PDF) (Word)

West Nile Virus Activity-US, November 6-12, 2003 (HTM)

Reprints: Freezing and Storage Temperatures for Source Plasma and Fresh Frozen Plasma (HTM) (PDF) (Word)

Memorandum Regarding Blood Donor Deferral for Leishmaniasis in Iraq (PDF)