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| Most Recent
2005D-0203:
Guidance for Industry on Safety Testing of Drug Metabolites
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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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| 06/06/2005
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| 06/06/2005
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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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| 06/03/2005
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| FDA
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| FDA
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| 06/06/2005
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| 32839-32839
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| EMC1
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| 06/09/2005
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| 06/09/2005
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| Individual Consumer
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| B. Sachau
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| EMC2
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| 06/07/2005
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| 06/07/2005
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| Food Industry
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| Kraft Foods Global,
Inc. (Kraft)
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| pdf
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| Signature:
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| Barbara Yehling and Sheryl A.
Marcou
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| EC1
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| 07/28/2005
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| 07/26/2005
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| Drug Industry
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| Alcon Research, Ltd.
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| htm
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| Signature:
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| Heidel, Garry
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| C1
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| 08/01/2005
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| 07/29/2005
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| Drug Industry
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| Boehringer Ingelheim
Pharmaceuticals Inc
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| pdf
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| Signature:
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| Brian A Walter PhD
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| C2
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| 08/03/2005
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| 08/02/2005
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| Drug Industry
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| Eli Lilly and Company
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| pdf
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| Signature:
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| John L Vahle DVM PhD DACVP
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| C3
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| 08/03/2005
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| 08/03/2005
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| Drug Industry
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| Sanofi-Synthelabo
Inc, Aventis Pharmaceuticals
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| pdf
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| Signature:
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| Steve Caffe MD
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| C4
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| 08/04/2005
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| 08/03/2005
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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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| Michael Garvin, PharmD
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| C5
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| 08/04/2005
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| 08/03/2005
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| Drug Industry
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| Millennium Pharmaceuticals,
Inc. (Millennium)
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| pdf
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| Signature:
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| Robert G. Pietrusko, PharmD
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| C6
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| 08/05/2005
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| 08/04/2005
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| Drug Industry
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| AtraZeneca Pharmaceuticals,
LP
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| pdf
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| Signature:
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| Carol A. Stinson
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| C7
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| 08/05/2005
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| 08/04/2005
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| Drug Industry
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| Pfizer, Inc.
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| pdf
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| Signature:
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| Susan S. Mattano, PhD., D.A.B.T.
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| EC2
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| 08/05/2005
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| 08/03/2005
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| Drug Industry
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| Johnson
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| htm,
Attachment
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| Signature:
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| Van Caurteren, Herman
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| EC3
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| 08/05/2005
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| 08/04/2005
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| Drug Industry
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| Amgen
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| htm,
Attachment
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| Signature:
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| Peters, Jenny
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| EC4
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| 08/05/2005
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| 08/04/2005
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| Drug Industry
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| Amgen
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| htm,
Attachment
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| Signature:
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| Peters, Jenny
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| EC5
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| 08/05/2005
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| 08/04/2005
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| Drug Industry
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| Pfizer
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| htm,
Attachment
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| Signature:
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| Mattano, Susan
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| EC6
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| 08/05/2005
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| 08/04/2005
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| Drug Industry
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| GlaxoSmithKline
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| htm,
Attachment
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| Signature:
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| Stokley, M.S.P.H., Anne
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| EC7
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| 08/05/2005
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| 08/04/2005
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| Drug Industry
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| Novartis Pharmaceuticals
Inc.
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| htm
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| Signature:
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| Madani, Soraya
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| EC8
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| 08/05/2005
|
| 08/04/2005
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| Drug Industry
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| Novartis Pharmaceuticals
Inc.
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| htm,
Attachment
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| Signature:
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| Madani, Soraya
| |
Top | Up
| Most Recent
Page last updated
August 31, 2005
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