Food and Drug Administration

Blood Products Advisory Committee Meeting

March 9, 2006

Slides

The Secretary's Advisory Committee on Blood Safety and Availability, John O. Agwunobi, MD, Ph.D. (ppt) (htm)

Current Considerations for Blood Donor Screening for West Nile Virus, Pradip N. Akolkar, Ph.D., Maria Rios, Ph.D. DETTD, OBRR (ppt) (htm)

Update on Transfusion Safety Management Systems, Linda Weir, CSO (pdf) (htm)

FDA Workshop on Behavior-Based Donor Deferrals in the NAT ERA, Andrew I. Dayton, MD, Ph.D. (ppt) (htm)

Behavior-Based Blood Donors Deferrals in the Era of Nucleic Acid Testing (NAT), Steven Kleinman, MD, AABB (pdf) (htm) (Added 4/7/06)

Rapid Tests for Detection of Bacterial Contamination of Platelets for Transfusion, Jaro Vostal, MD, PhD (ppt) (htm)

Draft Guidance: Collection of Platelets by Automated Methods, Alan E. Williams, Ph.D. (ppt) (htm)

Donor Deferral Due to Intake of Anti-Platelet Medication, Sharyn Orton, Ph.D. (ppt) (htm)

Potential Impacts on Availability of the Draft Plateletpheresis Guidance on Collection Facilities, Louis M. Katz, MD (ppt) (htm)

- Open Public Hearing Speakers -

BacTx™ Kit for Detection of Bacterial Contamination of Platelets, Andrew E. Levin, Ph.D. (ppt) (htm) (Added 4/7/06)

Rapid Bacterial Detection System (ppt) (htm)

Verax Biomedical Platelet PGD Test (ppt) (htm)

Baterial Contamination of Platelets, Michael R. Jacobs, MD, Ph.D. (ppt) (htm)

Comments on Draft Guidance: Collection of Platelets by Automated Methods, Richard Benjamin, MD, Ph.D. (ppt) (htm)

- Added 4/7/06 -

Bacteriological Biosensor for Rapid Screening of Platelets Shortly Before Transfusion, Boris Rotman, Ph. D.. BCR Diagnostics (ppt) (htm)

Innovations for a Secure and Healthy World, Jim Fleming, Chief Technology Officer, GenPrime (ppt) (htm) (Added 4/7/06)

Rapid Tests for Detection of Bacterial Contamination of Platelets, Steven Kleinman, MD (pdf) (htm)

Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods, Steven Kleinman, MD (pdf) (htm)

Comments by A. David Paltiel, MBA, PhD, Yale School of Medicine  and Rochelle P. Walensky, MD, MPH, Harvard Medical School  (htm)

Comments on “Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods (Draft)”, Dr. Richard Benjamin, MD, PhD, American Red Cross (pdf) (htm)

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