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2005D-0112:
Guidance for Industry on Clinical Trial Endpoints for the Approval
of Cancer Drugs and Biologics
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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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| 04/01/2005
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| 04/01/2005
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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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| 04/01/2005
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| FDA
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| FDA
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| 04/04/2005
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| 17095-17095
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| 06/03/2005
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| C1
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| 05/31/2005
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| 05/27/2005
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| International Industry
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| Eortc Data Center
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| pdf
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| Signature:
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| Richard Sylvester, ScD
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| C2
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| 06/03/2005
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| 06/03/2005
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| Private Industry
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| Bristol-Myers Squibb
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| pdf
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| Signature:
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| Donna Morgan Murray, Ph.D.
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| C3
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| 06/03/2005
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| 06/02/2005
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| Private Industry
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| Genentech
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| pdf
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| Signature:
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| Robert L. Carnick, Ph.D.
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| C4
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| 06/08/2005
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| 06/08/2005
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| Private Industry
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| Millennium Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Robert G. Pietrusko, Pharm.
D.
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| C5
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| 06/06/2005
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| 06/06/2005
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| Private Industry
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| AstraZeneca
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| Table
of Contents
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| Signature:
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| Ronald C. Falcone
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| EC1
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| 06/17/2005
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| 05/26/2005
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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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| Watson, Robert
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| EC2
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| 06/17/2005
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| 06/01/2005
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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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| Peters, Jenny
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| EMC1
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| 06/03/2005
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| 06/03/2005
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| Drug Industry
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| Merck & Co., Inc.
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| pdf
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| Signature:
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| Taryn Rogalski-Salter, PhD
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| EC3
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| 06/27/2005
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| 06/03/2005
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| Drug Industry
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| Pfizer
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| htm
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| Signature:
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| Russell, Alison
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| EC4
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| 06/27/2005
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| 06/03/2005
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| Health Care
Association
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| American Society of
Clinical Oncology
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| htm
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| Signature:
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| Horning, Sandra
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| EC5
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| 06/27/2005
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| 06/03/2005
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| Consumer Group
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| Cancer Leadership
Council
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| htm
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| Signature:
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| Stovall, Ellen
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| EC6
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| 06/27/2005
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| 06/03/2005
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| Consumer Group
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| Colorectal Cancer
Coalition
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| pdf
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| Signature:
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| Roach, Nancy
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| EC7
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| 06/27/2005
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| 06/03/2005
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| Drug Industry
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| Dr. Cheryl Anderson
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| htm
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| Signature:
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| Anderson, Cheryl
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| EC8
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| 06/27/2005
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| 06/03/2005
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| Drug Industry
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| Eli Lilly and Company
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| htm
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| Signature:
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| Anderson, Cheryl
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| EMC2
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| 06/03/2005
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| 06/03/2005
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| Association
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| American Society of
Clinical Oncology
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| pdf
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| Signature:
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| Sandra J Horning MD
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| EMC3
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| 06/03/2005
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| 06/03/2005
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| Drug Industry
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| Merck & Co. Inc
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| pdf
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| Signature:
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| Taryn Rogalski-Salter, PhD
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| EMC4
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| 06/03/2005
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| 06/03/2005
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| Drug Industry
|
| Abbott Global Medical
and Scientific Affairs
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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
July 13, 2005
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