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2005D-0183:
GUIDANCE FOR INDUSTRY ON ANTIVIRAL DRUG DEVELOPMENT CONDUCTING VIROLOGY
STUDIES AND SUBMITTING THE DATA TO THE AGENCY
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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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| 05/24/2005
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| 05/24/2005
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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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| 05/24/2005
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| FDA
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| FDA
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| 05/25/2005
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| 30127-30128
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| 07/25/2005
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| pdf
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| Signature:
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| Jeffrey Shuren
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| C1
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| 07/20/2005
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| 07/19/2005
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| Drug Industry
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| Bristol-Myers Squibb
(BMS)
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| pdf
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| Signature:
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| Richard L. Wolgemuth, PhD
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| C2
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| 07/22/2005
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| 07/21/2005
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| Drug Industry
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| Gilead Sciences, Inc.
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| pdf
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| Signature:
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| Christophe Beraud, PhD
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| EC1
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| 07/28/2005
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| 07/22/2005
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| Drug Industry
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| Hoffmann-La Roche,
Inc.
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| Attachments: 01,
02
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| Signature:
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| Conrad, Robin L.
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| EC2
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| 07/28/2005
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| 07/25/2005
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| Drug Industry
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| Pfizer Inc
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| htm
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| Signature:
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| Hammond, Jennifer
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| EC3
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| 07/28/2005
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| 07/25/2005
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| Drug Industry
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| Trimeris, Inc
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| pdf
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| Signature:
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| Smiley, Lynn
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| EC4
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| 07/28/2005
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| 07/25/2005
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| Drug Industry
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| Schering-Plough
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| htm
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| Signature:
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| Trout, Gretchen
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| EC5
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| 07/28/2005
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| 07/25/2005
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| Drug Industry
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| GlaxoSmithKline
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| pdf
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| Signature:
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| Watts, Ph.D., Susan
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| EMC1
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| 07/25/2005
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| 07/25/2005
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| Private Industry
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| Abbott
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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
August 17, 2005
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