2006N-0464:
Electronic Submission of Regulatory Information, and Creating an
Electronic Platform for Enhanced Information Management; Public
Hearing
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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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| NHC1
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| 11/16/2006
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| FDA
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| FDA
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| 11/21/2006
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| 67356-67359
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| 12/08/2006
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| txt
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| Signature:
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| Janet Woodcock
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| EC1
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| 11/28/2006
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| 11/27/2006
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| Drug Industry
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| Genzyme Corporation
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| htm
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| Signature:
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| Carle, Rachel
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| APE1
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| 11/28/2006
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| 11/27/2006
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| Private Industry
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| Piedmont Medical Group
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| pdf
Attached CV
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| Signature:
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| Doug Pierce
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| EC2
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| 12/05/2006
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| 12/01/2006
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| Device Industry
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| AGA Medical
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| htm
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| Signature:
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| Rutkiewicz, Mark
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| EC3
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| 12/06/2006
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| 12/05/2006
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| International Industry
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| Newtech Global Solutions
LLC
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| htm
Attachment
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| Signature:
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| Kaliannan, Ari
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| EC4
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| 12/07/2006
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| 12/06/2006
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| Drug Association
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| Pharm Res
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| pdf
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| Signature:
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| Goldhammer, Alan
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| EC5
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| 12/08/2006
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| 12/07/2006
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| Private Industry
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| Virtify, Inc.
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| htm
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| Signature:
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| Tadikonda, Satish
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| EC6
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| 12/08/2006
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| 12/07/2006
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| Drug Industry
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| TAP Pharmaceutical
Products Inc
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| htm
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| Signature:
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| Edwards, S. Albert
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| EC7
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| 12/08/2006
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| 12/07/2006
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| Private Industry
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| Datafarm Inc.
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| htm
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| Signature:
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| McNiff, Sean
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| EC8
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| 12/08/2006
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| 12/07/2006
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| Health Professional
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| GlobalSubmit
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| htm
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| Signature:
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| Rock, Jason
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| APE2
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| 12/08/2006
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| 12/08/2006
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| Private Industry
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| Alston & Bird
LLP
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| pdf
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| Signature:
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| Donald E. Segal
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| EC9
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| 12/11/2006
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| 12/08/2006
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| Drug Association
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| Biotechnology Industry
Organization (BIO)
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| htm
Attachment
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| Signature:
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| Emmett, Andrew
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| EC10
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| 12/11/2006
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| 12/08/2006
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| International Organization
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| CDISC
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| htm
Attachment
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| Signature:
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| Mason, Tanyss
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| EC11
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| 12/11/2006
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| 12/08/2006
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| Other Organization
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| CRIX International,
Association
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| htm
Attachment
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| Signature:
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| Tallent, Guy
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| EC12
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| 12/11/2006
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| 12/08/2006
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| Drug Industry
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| Mr. Robert Rainer
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| htm
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| Signature:
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| Rainer, Robert
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| EC13
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| 12/11/2006
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| 12/08/2006
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| Private Industry
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| Octagon Research Solutions
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| htm
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| Signature:
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| Smerkanich, nancy
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| EC14
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| 12/11/2006
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| 12/08/2006
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| Drug Industry
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| Genzyme Corporation
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| htm
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| Signature:
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| Panagoulias, Jennifer
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| EC15
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| 12/11/2006
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| 12/08/2006
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| Private Industry
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| SAS
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| pdf
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| Signature:
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| Lang, Sharon
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| EC16
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| 12/11/2006
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| 12/08/2006
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| Drug Industry
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| CommonPractice.org
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| pdf
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| Signature:
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| Luce, David
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| EC17
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| 12/11/2006
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| 12/08/2006
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| Private Industry
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| ThinSpring
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| htm
Attachment
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| Signature:
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| Celeste, Ron
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| EC18
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| 12/11/2006
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| 12/08/2006
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| Drug Industry
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| Genentech, Inc.
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| pdf
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| Signature:
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| van Gelder, Jan
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| EC19
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| 12/11/2006
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| 12/08/2006
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| Individual Consumer
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| MedWrite, Inc.
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| htm
Attachment
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| Signature:
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| Wood, Linda
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| EC20
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| 12/11/2006
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| 12/08/2006
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| Private Industry
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| Northrop Grumman Corporation
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| Table
of Contents
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| Signature:
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| Zagar, Terence
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| EC21
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| 12/12/2006
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| 12/11/2006
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| Drug Association
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| Pharm Res
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| pdf
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| Signature:
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| Goldhammer, Alan
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| C1
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| 12/11/2006
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| 12/05/2006
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| Private Industry
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| Comprehensive Clinical
Trials, LLC
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| pdf
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| Signature:
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| Virginia Piechocniski
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| APE3
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| 12/08/2006
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| 12/08/2006
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| Private Industry
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| Alston & Bird,
LLP
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| pdf
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| Signature:
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| Donald E. Segal
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| EC22
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| 12/14/2006
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| 12/12/2006
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| Drug Industry
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| Dr. S. Albert Edwards
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| pdf
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| Signature:
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| Edwards, S. Albert
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| EC23
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| 12/14/2006
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| 12/13/2006
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| Private Industry
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| Northrop Grumman Corporation
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| htm
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| Signature:
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| Zagar, Terence
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| EMC1
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| 12/06/2006
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| 12/05/2006
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| Private Industry
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| NGS, Newtech Global
Soluctions LLC
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| pdf
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| Signature:
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| Ari Kaliannan
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| LST1
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| 12/14/2006
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| 12/14/2006
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| Federal Government
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| Panelists for the
Part 15 Public Hearing
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| pdf
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| Signature:
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| Panelists for the Part 15 Public
Hearin
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| LST2
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| 12/14/2006
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| 12/14/2006
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| Federal Government
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| Part 15 Public Hearing
Schedule
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| pdf
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| Signature:
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| Part 15 Public Hearing Schedule
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| EC24
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| 12/15/2006
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| 12/14/2006
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| Drug Industry
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| Octagon Research Solutions
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| htm
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| Signature:
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| Smerkanich, Nancy
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| EC25
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| 12/18/2006
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| 12/15/2006
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| Drug Industry
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| Hollister-Stier Laboratories
LLC
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| pdf
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| Signature:
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| Mirabell, David
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| EC26
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| 12/18/2006
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| 12/15/2006
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| Private Industry
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| SAS
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| htm
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| Signature:
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| McFadden, Lee
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| EC27
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| 12/18/2006
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| 12/15/2006
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| Private Industry
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| Northrop Grumman Corporation
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| htm
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| Signature:
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| Zagar, Terence
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| C2
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| 12/18/2006
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| 12/15/2006
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| Drug Industry
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| Ciba Specialty Chemicals
Corporation (Ciba)
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| pdf
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| Signature:
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| Michael Ruberto, PhD
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| TS1
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| 12/15/2006
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| 12/14/2006
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| Private Industry
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| Alston & Bird,
LLP
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| pdf
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| Signature:
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| Donald E. Segal
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| EMC2
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| 12/20/2006
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| 12/19/2006
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| Drug Industry
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| Isis Pharmaceuticals
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| pdf
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| Signature:
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| Kim M. Johnson
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| EC28
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| 12/26/2006
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| 12/22/2006
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| Association
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| Cyber Security Industry
Alliance
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| htm
Att 1, Att
2
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| Signature:
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| Kurtz, Paul
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| EMC3
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| 12/29/2006
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| 12/29/2006
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| Private Industry
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| St. Jude Children's
Research Hospital
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| txt
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| Signature:
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| Robert S. Lake, D. Mgt., M.
A., R. A. C
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| EC29
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| 01/19/2007
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| 01/17/2007
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| Drug Industry
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| Dr. John Aitken
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| htm
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| EC30
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| 01/19/2007
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| 01/18/2007
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| Other Organization
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| CRIX International,
Association
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| htm
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| Signature:
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| Tallent, Guy
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| TR1
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| 02/05/2007
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| 02/05/2007
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| Federal Government
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| Transcript of the 12/18/06 Public Meeting
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| rtf
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| Signature:
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| Transcript
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| TS2
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| 02/05/2007
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| 02/05/2007
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| Private Industry
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| TAP Pharmaceutical Products, Inc.
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| htm
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| The Desired (Required) State of Electronic Submissions
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| Signature:
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| Dr. S. Albert Edwards
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| TS3
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| 02/05/2007
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| 02/05/2007
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| Private Industry
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| Clinical Ink TM
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| htm
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| Digital Source Documents
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| Signature:
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| Clinical Ink TM
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| TS4
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| 02/05/2007
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| 02/05/2007
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| Private Industry
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| ThinSpring
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| htm
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| Electronic Submission of Regulatory Information
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| Signature:
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| Ron Celeste
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| TS5
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| 02/05/2007
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| 02/05/2007
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| Private Industry
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| CDISC
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| htm
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| Clinical Data Interchange Standards Consortium
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| Signature:
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| C. David Hardison, PhD and Wayne K
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| TS6
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| 02/05/2007
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| 02/05/2007
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| Private Industry
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| Surety, LLC
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| htm
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| Obstacles Faced by Going to an All-electronic Submission Environment
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| Signature:
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| Tom Klaff
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| TS7
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| 02/05/2007
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| 02/05/2007
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| Private Industry
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| Octagon Research Solutions, Inc.
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| htm
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| Transition to and Implementation of Electronic Submissions
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| Signature:
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| Nancy Smerkanich
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| TS8
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| 02/05/2007
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| 02/05/2007
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| Private Industry
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| Alston & Bird LLP
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| htm
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| Transition from Paper Submissions to Electronic Submissions
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| Signature:
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| Marc J. Scheineson, Esq. and Donal E
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| TS9
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| 02/05/2007
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| 02/05/2007
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| Other Organization
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| Clinical Research Information Exchange CRIX
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| htm
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| Signature:
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| Clinical Research Information Exchang
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| TS10
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| 02/05/2007
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| 02/05/2007
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| Private Industry
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| Pharmaceutical Research and Manufactureres of America (PhRMA)
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| htm
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| FDA Public Hearing on Electronic Submissions and Public-Private Partnerships
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| Signature:
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| Ed Tripp, Abbot, and Bill Rosen, Pfize
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| TS11
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| 02/05/2007
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| 02/05/2007
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| Private Industry
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| JRRapoza Associates, Inc. and Newtech Global Solutions LLC
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| htm
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| Signature:
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| John R. Rapoza, M.S., R.Ph. and Ari
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| TS12
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| 02/05/2007
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| 02/05/2007
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| Private Industry
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| AGA Medical Corporation
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| htm
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| Best Practices in Sharing Electronic Documentation in the Medical Device Industry
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| Signature:
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| Mark Rutkiewicz
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| TS13
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| 02/05/2007
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| 02/05/2007
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| Private Industry
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| GlobalSubmit, Inc.
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| htm
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| Reducing the Cost of Electronic Submissions
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| Signature:
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| Jason Rock
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| TS14
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| 02/05/2007
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| 02/05/2007
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| Private Industry
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| Northrop Grumman
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| htm
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| Defining the Future
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| Signature:
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| Robert M. Cothren, PhD, Harry Fisher
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Top | Up Page last updated:
February 21, 2007
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