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2007D-0089:
Guidance for Industry and Review Staff on Target Product Profile
A Strategic Development Process Tool
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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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| NAD1
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| 03/29/2007
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| FDA
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| FDA
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| 03/30/2007
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| 15141-15142
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| 05/29/2007
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| txt
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| Signature:
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| Jeffrey Shuren
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| GDL1
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| 03/29/2007
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| 03/29/2007
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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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| EC1
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| 05/30/2007
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| 05/23/2007
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| Drug Industry
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| Johnson and Johnson
PRD
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| pdf
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| Signature:
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| Boselli, Bruce
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| EC2
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| 05/30/2007
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| 05/24/2007
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| Drug Industry
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| AstraZeneca LP
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| pdf
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| Signature:
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| Orzolek, Robert
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| EC3
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| 05/30/2007
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| 05/25/2007
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| Drug Industry
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| Pfizer
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| pdf
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| Signature:
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| Murphy, William
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| EC4
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| 05/30/2007
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| 05/29/2007
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| Drug Industry
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| Novartis Pharmaceuticals
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| htm
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| No attachment received
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| Signature:
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| Madani, Soraya
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| EC5
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| 05/30/2007
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| 05/29/2007
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| Drug Industry
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| Merck Research Laboratories
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| pdf
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| Signature:
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| Mayhew, Brian
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| EC6
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| 05/30/2007
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| 05/29/2007
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| Drug Industry
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| sanofi-aventis
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| pdf
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| Signature:
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| Bowen, Linda
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| EC7
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| 05/30/2007
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| 05/29/2007
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| Drug Industry
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| Amgen
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| htm
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| No attachment received
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| Signature:
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| Hollister, Kevin
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| C1
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| 05/25/2007
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| 05/24/2007
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| Drug Industry
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| Bristol-Myers Squibb
Company
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| pdf
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| Signature:
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| Joseph F Lamendola PhD
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| C2
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| 05/25/2007
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| 05/24/2007
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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 Jr
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| EMC1
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| 05/29/2007
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| 05/29/2007
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| Drug Industry
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| Novartis Pharmaceutical
Corporation
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| pdf
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| Signature:
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| Georgia Tarnesby MD, Soraya
Madan
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| EMC2
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| 05/29/2007
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| 05/29/2007
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| Drug Industry
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| Abbott Laboratories
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| pdf
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| Signature:
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| Douglas L Sporn
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Top
| Up
Page last updated:
June 1, 2007
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