Up
2005D-0286:
Draft Guidance for Industry on INDs Approaches to Complying with
CGMP During Phase 1; Availability
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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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| GDL1
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| 01/17/2006
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| 01/17/2006
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| Federal Government
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| Guidance
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| pdf
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| NAD1
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| 01/17/2006
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| FDA
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| FDA
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| 01/17/2006
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| 2552-2554
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| 03/20/2006
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| txt
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| Signature:
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| Jeffrey Shruen
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| EMC1
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| 02/08/2006
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| 02/08/2006
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| Individual Consumer
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| B. Sachau
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| C1
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| 03/07/2006
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| 02/27/2006
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| Private Industry
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| Elemental Research,
Inc.
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| pdf
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| Signature:
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| Mercedes Stuart
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| C2
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| 03/14/2006
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| 03/10/2006
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| Drug Industry
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| pdf
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| Signature:
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| Alice E. Till, PhD
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| C3
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| 03/20/2006
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| 03/17/2006
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| Drug Industry
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| Cambrex Corporation
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| pdf
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| Signature:
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| Barbara B. Zinck
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| C4
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| 03/16/2006
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| 03/14/2006
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| Drug Industry
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| Novartis Pharmaceuticals
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| pdf
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| Signature:
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| Kathleen Greene
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| C5
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| 03/16/2006
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| 03/15/2006
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| Drug Industry
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| Amgen
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| pdf
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| Signature:
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| Barbara W. Unger
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| C6
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| 03/16/2006
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| 03/15/2006
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| Health Care Association
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| GE HEalthcare
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| pdf
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| Signature:
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| Fred Longenecker
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| C7
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| 03/20/2006
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| 03/17/2006
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| Drug Industry
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| Chiron Corporation
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| pdf
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| Signature:
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| Gia D. DePillis, PhD
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| C8
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| 03/20/2006
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| 03/17/2006
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| Drug Association
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| Parenteral Drug Association
(PDA)
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| pdf
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| Signature:
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| Richard V. Levy, PhD
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| C9
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| 03/20/2006
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| 03/17/2006
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| Drug Industry
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| Abbott
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| pdf
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| Signature:
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| Zena Kaufman
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| C10
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| 03/21/2006
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| 03/20/2006
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| Drug Industry
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| Wyeth Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Roy J. Baranello
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| EMC2
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| 03/20/2006
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| 03/20/2006
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| International Industry
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| Japan Society of Pharmaceutical
Machinery and Engineering (JSPME)
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| pdf
Attachment
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| Signature:
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| Katsuhide Terada, PhD
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| EMC3
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| 03/21/2006
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| 03/21/2006
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| Drug Industry
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| Biotechnology Industry
Organization (BIO)
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| pdf
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| Signature:
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| Sara Radcliffe
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| C11
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| 03/29/2006
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| 03/20/2006
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| International Industry
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| Japan Society of Pharmaceutical
Machinery and Engineering (JSPME)
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| pdf
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| Signature:
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| KAtsuhide Terada, PhD
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| C12
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| 03/30/2006
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| 03/27/2006
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| Drug Industry
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| Schering-Plough
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| pdf
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| Signature:
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| Gretchen Trout
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| C13
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| 04/18/2006
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| 04/13/2006
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| Device Association
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| International Society for Pharmaceutical Engineering (ISPE)
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| pdf
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| Signature:
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| Robert P. Best
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| C14
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| 04/21/2006
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| 04/20/2006
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| Drug Industry
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| Bristol-Myers Squibb
Company (BMS)
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| pdf
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| Signature:
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| Richard L. Wolgemuth, PhD
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| EC1
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| 04/26/2006
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| 03/13/2006
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| Drug Industry
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| Novartis Pharmaceutical
Corp.
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| pdf
Attachment
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| Signature:
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| Greene, Kathleen
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| EC2
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| 05/01/2006
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| 03/20/2006
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| Drug Industry
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| AstraZeneca
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| pdf
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| Signature:
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| Damstetter , Philip
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| EC3
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| 05/01/2006
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| 03/20/2006
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| Drug Association
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| PDA
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| htm
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| Signature:
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| Dana, Robert
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| EC4
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| 05/01/2006
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| 03/20/2006
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| Health Professional
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| LearningPlus
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| pdf
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| Signature:
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| Vesper, James
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| EC5
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| 05/01/2006
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| 03/20/2006
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| Drug Industry
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| Takeda Global Research
and Development Center, Inc
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| pdf
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| Signature:
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| Rojewski, Chris
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| EC6
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| 05/01/2006
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| 03/20/2006
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| Drug Industry
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| Schering-Plough
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| pdf
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|
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| Signature:
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| Crew, Jacqueline
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| EC7
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| 05/01/2006
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| 03/20/2006
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| Drug Industry
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| Johnson
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| pdf
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| Signature:
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| Kowtna, Christopher
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| EC8
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| 05/01/2006
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| 03/20/2006
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| Drug Industry
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| Sanofi Pasteur
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| pdf
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|
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| Signature:
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| Guito, Ken
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| EC9
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| 05/01/2006
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| 03/21/2006
|
| Private Industry
|
| Immel Resources LLC
|
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| pdf
Att
1, Att 2
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|
|
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| Signature:
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| Immel, Barbara
| |
Top | Up
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Page last updated
May 25, 2006
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