| Up
2005D-0022:
INTERNATIONAL CONFERENCE ON HARMONISATION; DRAFT GUIDANCE ON S8
IMMUNOTOXICITY STUDIES FOR HUMAN PHARMACEUTICALS
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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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| 02/08/2005
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| 02/08/2005
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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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| 02/07/2005
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| FDA
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| FDA
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| 02/08/2005
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| 6697-6698
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| 04/11/2005
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| pdf
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| Signature:
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| Jeffrey Shuren
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| EMC1
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| 03/16/2005
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| 03/16/2005
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| Drug Industry
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| Abbott Laboratories
(Abbott)
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| pdf
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| Signature:
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| Douglas L. Sporn
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| EC1
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| 03/22/2005
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| 03/21/2005
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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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| Stokley, M.S.P.H.,
Anne
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| EMC2
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| 04/11/2005
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| 04/11/2005
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| Drug Industry
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| Biotechnology Industry
Organization (BIO)
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| doc,
pdf
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| Signature:
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| Sara Radcliffe
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| EMC3
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| 04/11/2005
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| 04/11/2005
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| Drug Industry
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| Merck & Co., Inc
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| txt,
Attachment pdf, doc
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| Signature:
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| Taryn Rogalski-Salter,
PhD
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| EMC4
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| 04/11/2005
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| 04/11/2005
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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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| Jenny Peters
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| C1
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| 04/06/2005
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| 04/05/2005
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| Drug Industry
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| Lilly Research Laboratories
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| pdf
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| Signature:
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| Timothy R. Franson,
MD
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| C2
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| 04/12/2005
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| 04/12/2005
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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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| Steve Caffe, MD
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| EC2
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| 05/02/2005
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| 04/11/2005
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| International Organization
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| ILSI Health and Environmental
Sciences Institute
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| pdf
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| Signature:
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| Faherty, Ciaran
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Top
| Up
Page last updated
July 11, 2005
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