Up
2005D-0330:
Guidance for Industry and FDA Review Staff on Collection of Platelets
by Automated Methods
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| BKG1
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| 09/30/2005
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| 09/30/2005
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| Federal
Government
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| Background Information
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| Table
of Contents
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| Signature:
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| Background Information
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| GDL1
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| 09/30/2005
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| 09/30/2005
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| Federal
Government
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| Guidance
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| pdf
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| Signature:
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| Guidance
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| NAD1
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| 09/30/2005
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| FDA
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| FDA
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| 10/03/2005
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| 57609-57610
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| 01/03/2006
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| C1
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| 10/24/2005
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| 10/21/2005
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| Private Industry
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| Dartmouth-Hitchcock
Medical Center
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| pdf
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| Signature:
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| James P. AuBuchon, MD
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| C2
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| 11/16/2005
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| 11/14/2005
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| Private Industry
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| Aultman Hospital,
Department of Pathology
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| pdf
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| Signature:
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| Daniel Wasdahl MD
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| C3
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| 11/29/2005
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| 11/23/2005
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| Private Industry
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| Arlington Memorial
Hospital
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| pdf
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| Signature:
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| J. Trace Worrell, MD and Mary
Kenned
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| C4
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| 11/29/2005
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| 11/28/2005
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| Private Industry
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| Haemonetics Corporation
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| pdf
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| Signature:
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| John J. Sokolowski
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| EC1
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| 12/05/2005
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| 11/22/2005
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| Health Care
Association
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| Scott
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| htm
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| Signature:
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| Currie, Robert
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| EC2
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| 12/05/2005
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| 11/28/2005
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| Health Professional
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| University of Michigan
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| htm
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| Signature:
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| Davenport, Robertson
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| EC3
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| 12/05/2005
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| 11/29/2005
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| Health Professional
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| Heartpumper, Inc.
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| htm
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| Signature:
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| Raley, Rick
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| C5
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| 12/01/2005
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| 11/28/2005
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| Private Industry
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| Baylor Medical Center
at Irving
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| pdf
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| Signature:
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| T Dickey MD, Judy Barnes MT
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| C6
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| 12/19/2005
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| 12/14/2005
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| Private Industry
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| BloodSource
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| pdf
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| Signature:
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| David Witthaus
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| C7
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| 12/16/2005
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| 12/15/2005
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| Academia
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| University of Texas
MD Anderson Cancer Center
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| pdf
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| Signature:
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| Benjamin Lichtiger MD PHD, Kathleen
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| C8
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| 12/20/2005
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| 12/15/2005
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| Academia
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| University of Iowa
Hospitals & Clinics
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| pdf
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| Signature:
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| Christine M Hillberry MT(ASCP
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| EXT1
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| 12/21/2005
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| 12/15/2005
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| Private Industry
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| Blood and Tissue Center
of Central Texas
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| pdf
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| Signature:
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| Marian L Garrard
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| EXT2
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| 12/21/2005
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| 12/14/2005
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| Private Industry
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| Blood and Tissue Center
of Central Texas
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| pdf
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| Signature:
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| Tina R Revuelta MLT RN
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| EC4
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| 12/22/2005
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| 12/19/2005
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| Health Care
Association
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| Bergen Community Regional
Blood Center
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| htm
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| Signature:
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| Matrisciano, Jim
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| C9
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| 12/23/2005
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| 12/19/2005
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| Private Industry
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| Northwest Florida
Blood Center
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| pdf
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| Signature:
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| Scott G Robertson MT
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| C10
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| 12/27/2005
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| 12/21/2005
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| Private Industry
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| Lane Memorial Bloodbank
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| pdf
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| Signature:
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| Douglas A Engel
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Top | Up
Page last updated
January 3, 2006
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