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2004D0377:
INTERNATIONAL CONFERENCE ON HARMONISATION; DRAFT GUIDANCE ON E14
CLINICAL EVALUATION OF QT/QTC INTERVAL PROLONGATION AND PROARRHYTHMIC
POTENTIAL FOR NON-ANTIARRHYTHMIC DRUGS
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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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| 09/10/2004
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| 09/10/2004
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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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| 09/10/2004
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| FDA
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| FDA
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| 09/13/2004
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| 55163-55164
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| 12/13/2004
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| pdf
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| Signature:
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| HUBBARD, WILLIAM
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| C1
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| 11/04/2004
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| 11/02/2004
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| Drug Industry
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| Aventis
Pharmaceuticals, Inc.
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| pdf
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| Signature:
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| Steve Caffe, MD
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| EC1
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| 11/12/2004
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| 11/11/2004
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| Drug Industry
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| NUMBER NOT
USED
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| htm
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| Signature:
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| NUMBER NOT USED
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| EC2
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| 11/12/2004
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| 11/11/2004
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| Drug Industry
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| ChanTest,
Inc.
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| htm
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| Signature:
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| Brown, Arthur
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| EC3
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| 11/12/2004
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| 11/11/2004
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| Drug Industry
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| ChanTest,
Inc.
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| htm,
Attachment doc, pdf
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| Signature:
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| Brown, Arthur
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| C2
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| 11/15/2004
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| 11/12/2004
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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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| Alison Bowers
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| C3
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| 11/16/2004
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| 11/16/2004
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| Association
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| Council
on Radionuclides and Radiopharmaceuticals (CORAR) and the
Medical Imaging Contrast Agent Ass
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| pdf
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| Signature:
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| Alan M. Kirschenbaum
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| EC4
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| 11/14/2004
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| 11/12/2004
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| Drug Industry
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| Mrs. Alison
Bowers
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| htm,
Attachment doc, pdf
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| Signature:
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| Bowers, Alison
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| EC5
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| 11/14/2004
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| 11/12/2004
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| Drug Industry
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| GlaxoSmithKline
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| htm,
Attachment doc, pdf
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| Signature:
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| Bowers, Alison
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| EXT1
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| 12/13/2004
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| 12/13/2004
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| Drug Industry
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| Wyeth Pharmaceuticals
(Wyeth)
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| pdf
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| Signature:
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| Roy J. Baranello,
Jr.
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| C4
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| 12/10/2004
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| 12/09/2004
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| Drug Industry
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| Boehringer
Ingelheim Pharmcaceuticals, Inc.
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| 01pdf,
02pdf
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| Signature:
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| Heidi C. Reidies
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| C5
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| 12/10/2004
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| 12/10/2004
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| Drug Industry
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| Merck &
Co., INc.
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| pdf,
Attachment
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| Signature:
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| Lauren M. Hetrick
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| C6
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| 12/10/2004
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| 12/09/2004
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| Drug Industry
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| Bristol-Myers
Squibb Company
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| pdf
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| Signature:
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| Richard L. Wolgemuth,
PhD
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| EC6
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| 12/14/2004
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| 12/13/2004
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| Academia
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| Duke Clinical
Research Institute - Duke Univ.
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| htm,
Attachment doc, pdf
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| Signature:
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| Cabell, Christopher
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| EC7
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| 12/14/2004
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| 12/13/2004
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| Drug Industry
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| Pfizer Inc
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| htm,
Attachment
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| Signature:
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| Murphy, William
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| C7
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| 12/14/2004
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| 12/13/2004
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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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| William R. Murphy
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| C8
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| 12/13/2004
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| 12/13/2004
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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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Page last updated
January 24, 2005
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