|
2007D-0290:
Guidance for Industry: Cell Selection Devices for Point of Care
Production of Minimally Manipulated Autologous Peripheral Blood
Stem Cells (PBSCs)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
|
|
| NAD1
|
|
|
| 07/23/2007
|
| FDA
|
| FDA
|
| 07/26/2007
|
| 41080-41081
|
| 10/24/2007
|
| txt
|
|
|
|
|
| Signature:
|
| SHUREN, JEFFREY
|
|
|
|
|
| GDL1
|
| 07/23/2007
|
| 07/23/2007
|
| Federal Government
|
| Guidance
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| EC1
|
| 09/26/2007
|
| 09/19/2007
|
| Health Care Association
|
| AABB
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Giglio, Joseph
|
|
|
|
|
| EC2
|
| 10/18/2007
|
| 10/17/2007
|
| Academia
|
| Duke University Medical
Center
|
|
|
|
|
|
|
| htm
|
|
|
|
|
| Signature:
|
| Haley, Rebecca
|
|
|
|
|
| EC3
|
| 10/23/2007
|
| 10/22/2007
|
| Device Industry
|
| Biosafe
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Mottier, Frdric
|
|
|
|
|
| EC4
|
| 10/23/2007
|
| 10/22/2007
|
| Device Industry
|
| On behalf of device
company to remain anonymous
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Weber, Darin
|
|
|
|
|
| EC5
|
| 10/23/2007
|
| 10/22/2007
|
| Health Care Association
|
| American Society for
Apheresis
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Linenberger, Michael
|
|
|
|
|
| C1
|
| 10/24/2007
|
| 10/24/2007
|
| Drug Industry
|
| Hyman, Phelps &
McNamara (HPM)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Michelle Butler
|
|
|
|
|
| EC6
|
| 10/26/2007
|
| 10/24/2007
|
| Device Industry
|
| Baxter Healthcare
Corporation
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Seidman, Jesse
|
|
|
|
|
| EC7
|
| 10/26/2007
|
| 10/24/2007
|
| Device Industry
|
| Baxter Healthcare
Corporation
|
|
|
|
|
|
|
| htm
|
| No Attachment Included
|
|
|
| Signature:
|
| Seidman, Jesse
|
|
|
|
|
| EC8
|
| 10/26/2007
|
| 10/24/2007
|
| International Organization
|
| International Society
for Cellular Therapies
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Vasconcells, Joyce
|
|
|
|
|
| EC9
|
| 10/26/2007
|
| 10/24/2007
|
| Health Professional
|
| Dr. Joyce Vasconcells
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| C2
|
| 12/03/2007
|
| 12/03/2007
|
| Individual Consumer
|
| P. Alain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Top
| Up
Page last updated:
December 5, 2007
|
