| Up
| Next | Most Recent
2005D-0122:
Guidance for Industry on Exploratory IND Studies
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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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| 04/13/2005
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| 04/13/2005
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| Federal
Government
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| Guideline
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| pdf
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| Signature:
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| Guideline
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| NAD1
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| 04/13/2005
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| FDA
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| FDA
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| 04/14/2005
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| 19764-19765
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| 07/13/2005
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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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| 04/27/2005
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| 04/26/2005
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| Health Professional
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| D. Swanson, R.Ph,
M.S., BCNP, CIP
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| EMC1
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| 04/21/2005
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| 04/21/2005
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| Individual Consumer
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| B. Sachau
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| EC1
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| 05/04/2005
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| 04/29/2005
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| Drug Industry
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| Targa Therapeutics
Corp.
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| htm
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| Signature:
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| Aronson, Gary
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| C2
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| 06/23/2005
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| 06/22/2005
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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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| C3
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| 07/07/2005
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| 07/06/2005
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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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| EMC2
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| 07/08/2005
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| 07/08/2005
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| Consumer Group
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| RDRC #0038
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| pdf
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| Signature:
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| Henry Stauffer, MD, PhD
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| C4
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| 07/12/2005
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| 07/11/2005
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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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| Barry Sickels
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| C5
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| 07/12/2005
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| 07/11/2005
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| Drug Industry
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| GE Healthcare
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| pdf
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| Signature:
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| Fred Longenecker
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| C6
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| 07/12/2005
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| 07/11/2005
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| Drug Industry
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| Eli Lilly and Company
(Lilly)
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| pdf
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| Signature:
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| Bryan Boggs, PharmD, RAC and
John
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| C7
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| 07/13/2005
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| 07/12/2005
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| Drug Industry
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| GlaxoSmithKline (GSK)
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| pdf
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| Signature:
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| Mary Faye S. Whisler, PhD
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| C8
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| 07/13/2005
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| 07/09/2005
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| Health Professional
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| J. Coupal, PhD., BCNP
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| C9
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| 07/13/2005
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| 07/12/2005
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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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| Alice E. Till, PhD
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| C10
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| 07/13/2005
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| 07/13/2005
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| Health Professional
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| J. Coupal, PhD
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| C11
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| 07/14/2005
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| 07/13/2005
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| Drug Industry
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| Novartis Pharmaceuticals,
Corp.
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| pdf
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| Signature:
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| Robert J. Clark
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| C12
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| 07/14/2005
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| 07/12/2005
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| Drug Industry
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| Genentech
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| pdf
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| Signature:
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| Robert L. Garnick, PhD
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| EC2
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| 07/15/2005
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| 07/08/2005
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| Drug Association
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| EFPIA
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| pdf
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| Signature:
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| Callewaert, Stephane
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| EC3
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| 07/15/2005
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| 07/08/2005
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| International Industry
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| Xceleron Ltd
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| pdf
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| Signature:
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| Garner, Colin
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Top | Up
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Page last updated
August 11, 2005
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