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