Up
2006D-0191:
Guidance for Industry and Food and Drug Administration; Guidance
for the Use of Bayesian Statistics in Medical Device Clinical Trials
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| Document #
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| Received Date
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Date
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| Submitter Code
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Date
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Page
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| Remarks
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GDL1 |
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05/22/2006
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05/22/2006
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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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05/22/2006
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FDA |
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FDA |
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05/23/2006 |
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29651-29652
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08/21/2006
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txt |
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Signature: |
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Jeffrey Shuren |
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EC1 |
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06/05/2006
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05/26/2006
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Academia
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Texas Tech University
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htm |
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Signature: |
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Westfall, Peter |
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EC2 |
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06/06/2006
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06/05/2006
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Health Professional
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Vanderbilt University
School of Medicine |
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htm |
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Signature: |
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Harrell, Frank |
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C1 |
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06/06/2006
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06/06/2006
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International
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London School
of Hygiene and Tropical Medicine |
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pdf |
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Signature: |
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Dr. Stuart Pocock
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EC3 |
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06/29/2006
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06/27/2006
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Individual Consumer
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Dr. Michael
Messner |
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pdf |
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EC4 |
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06/29/2006
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06/27/2006
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Health Professional
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Johns Hopkins
Bloomberg SPH |
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htm |
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Signature: |
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Louis, Thomas |
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EC5 |
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06/29/2006
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06/28/2006
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Individual Consumer
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Dr. ANDREW HARTLEY
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pdf |
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NM1 |
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06/26/2006
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FDA |
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FDA |
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06/29/2006 |
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37084-37084
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08/21/2006
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txt |
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Signature: |
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Jeffrey Shuren |
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C2 |
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07/03/2006
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06/26/2006
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Academia
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New Jersey Medical
School - UMDNJ |
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pdf |
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Signature: |
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Michael Brimacombe, PhD
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EC6 |
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08/02/2006
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07/31/2006
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Drug Industry
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Alcon Laboratories
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htm |
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Signature: |
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Von Tress, Mark |
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EC7 |
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08/02/2006
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07/31/2006
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Academia
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Harbor-UCLA
Medical Center |
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pdf |
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Signature: |
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Lewis, Roger |
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LST1 |
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08/14/2006
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08/14/2006
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Federal Government |
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Agenda for July
27, 2006 Meeting |
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pdf |
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Signature: |
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Agenda for July 27, 2006
Meeting |
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TR1 |
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08/14/2006
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08/14/2006
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Federal Government |
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Transcript of
the July 27, 2006 meeting |
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txt |
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Signature: |
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Transcript of the July 27,
2006 meetin |
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TS1 |
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08/14/2006
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08/14/2006
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Federal Government |
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Center for Devices
and Radiological Health |
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pdf |
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An Introduction
to the Draft Document: The Use of Bayesian Statistics in the
Medical Device Clinical Trials |
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Signature: |
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Gregory Campbell, PhD
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TS2 |
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08/14/2006
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08/14/2006
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Federal Government |
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Center for Devices
and Radiological Health |
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pdf |
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Potential Advantages
and Disadvantages to the Bayesian Approach |
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Signature: |
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Gerry Gray, PhD |
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TS3 |
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08/14/2006
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08/14/2006
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Federal Government |
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Center for Devices
and Radiological Health |
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pdf |
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Bayesian Statistics:
Planning and Analyzing a Flexible Bayesian Clinical Trial |
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Signature: |
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Telba Irony, PhD
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TS4 |
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08/14/2006
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08/14/2006
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Federal Government |
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Center for Devices
and Radiological Health |
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pdf |
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Planning a
Bayesian trial: Prior Distributions and Hierarchical Models |
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Signature: |
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Gene Pennello, PhD
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TS5 |
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08/14/2006
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08/14/2006
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Federal Government |
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Center for Devices
and Radiological Health |
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pdf |
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Additional
Practical and Computational Issues: Potential Information
Requested by FDA |
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Signature: |
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Laura Thompson, PhD
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EC8 |
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08/15/2006
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08/14/2006
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Consumer Group
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Y-ME National
Breast Cancer Organization |
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htm |
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No attachment
received |
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Signature: |
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Wissmann, Kay |
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EC9 |
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08/15/2006
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08/14/2006
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Consumer Group
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Y-ME National
Breast Cancer Organization |
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htm |
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Signature: |
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Wissmann, Kay |
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EC10 |
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08/16/2006
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08/15/2006
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Health Professional
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Lutheran Social
Services |
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htm |
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Signature: |
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Morrison, Thomas
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EC11 |
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08/18/2006
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08/17/2006
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Private Industry
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Cytel Inc.
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htm |
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Signature: |
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Patel, Nitin |
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EC12 |
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08/21/2006
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08/20/2006
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Other Organization
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Royal Statistical
Society |
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pdf |
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Signature: |
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Spiegelhalter, David
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EC13 |
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08/22/2006
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08/21/2006
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Health Care
Association |
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Blue Cross and
Blue Shield Association |
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htm |
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Signature: |
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Aronson, Naomi |
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EC14 |
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08/22/2006
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08/21/2006
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Device Industry
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Alquest, Inc.
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pdf |
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Signature: |
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Lobbestael, Aaron
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EC15 |
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08/22/2006
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08/21/2006
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Academia
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University of
Minnesota |
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htm |
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Signature: |
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Mugglin, Andrew |
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EC16 |
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08/22/2006
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08/21/2006
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Private Industry
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CTRAPS
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pdf |
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Signature: |
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Engdahl, Karen |
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M1 |
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08/22/2006
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08/22/2006
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Federal Government |
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FDA/CBER to
DDMB |
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pdf |
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Signature: |
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Chinying Wang, PhD
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C3 |
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08/21/2006
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08/18/2006
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Drug Industry
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Abbott Laboratories
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pdf |
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Signature: |
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April Veoukas, J.D.
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C4 |
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08/21/2006
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08/21/2006
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Drug Industry
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sanofi-aventis
Group |
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pdf |
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Signature: |
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Richard Gural |
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C5 |
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08/23/2006
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08/18/2006
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Device Industry
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Alquest, Inc.
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pdf |
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Signature: |
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Aaron Lobbestael
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C6 |
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08/24/2006
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08/22/2006
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Private Industry
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Cook Group Inc.
(COOK) |
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pdf |
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Signature: |
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Scott Snyder, PhD
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EMC1 |
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08/18/2006
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08/18/2006
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International
Industry |
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Novartis Pharma
AG |
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txt
Attachment |
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Signature: |
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Dr. Beat Neuenschwander
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EMC2 |
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08/21/2006
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08/21/2006
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Individual Consumer
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No signature
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EMC3 |
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08/21/2006
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08/21/2006
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Individual Consumer
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B. Carlin
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EMC4 |
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08/21/2006
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08/21/2006
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Individual Consumer
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J Kadane
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EMC5 |
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08/21/2006
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08/21/2006
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Individual Consumer
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H. Lopes
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EMC6 |
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08/21/2006
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08/21/2006
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Academia
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S. Goodman,
MD, MHS, PhD |
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EMC7 |
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08/21/2006
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08/21/2006
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Individual Consumer
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Frank
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EMC8 |
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08/23/2006
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08/23/2006
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Individual Consumer
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C. Mehta and
N. Patel |
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EMC9 |
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08/23/2006
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08/23/2006
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Private Industry
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Consulants in
Toxicology |
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txt |
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Signature: |
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Karen L. Engdahl, B.F.A.
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EMC10 |
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08/23/2006
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08/23/2006
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Drug Industry
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Blue Cross
and Blue Shield Association (BCBSA) Technology Evaluation
Center (TEC) |
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pdf |
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Signature: |
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Naomi Aronson, PhD
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EMC11 |
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08/23/2006
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08/23/2006
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Private Industry
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Statisticians
in the Pharmaceutical Industry Limited |
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txt
Attachment |
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Signature: |
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Andrew Garrett |
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SUP1 |
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08/25/2006
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08/23/2006
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Private Industry
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Cook Group Inc.
(COOK) |
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pdf |
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Signature: |
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Scott Snyder, PhD
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