| Up
2006D-0088:
Guidance for Industry; Clinical Data Needed to Support the
Licensure of Pandemic Influenza Vaccines
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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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| 03/09/2006
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| 03/09/2006
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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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| 03/09/2006
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| FDA
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| FDA
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| 03/10/2006
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| 12366-12367
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| 06/08/2006
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| txt
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| Signature:
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| Jeffrey Shuren
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| BKG1
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| 03/10/2006
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| 03/10/2006
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| Federal Government
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| Background Material
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| Table
of Contents
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| Signature:
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| Background Material
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| EC1
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| 05/08/2006
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| 04/11/2006
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| Health Professional
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| Campbell University
School of Pharmacy
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| htm
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| Signature:
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| Johnson, Mary
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| EC2
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| 05/08/2006
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| 04/24/2006
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| Individual Consumer
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| Mr. Dave Lowe
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| htm
Attachment
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| C1
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| 06/01/2006
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| 05/25/2006
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| Private Industry
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| PowderMed Ltd
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| pdf
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| Signature:
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| David J. Gannaway, PhD
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| C2
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| 06/05/2006
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| 06/02/2006
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| Drug Industry
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| Novartis Vaccines
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| pdf
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| Signature:
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| Maurice W. Harmon, PhD., RAC
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| EC3
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| 06/06/2006
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| 05/25/2006
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| Drug Industry
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| PowderMed Ltd.
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| pdf
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| Signature:
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| Gannaway, David
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| C3
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| 06/06/2006
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| 06/06/2006
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| Federal Government
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| National Institutes
of Health (NIH)
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| pdf
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| Signature:
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| Kanta Subbarao, MD, MPH et al.
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| C4
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| 06/07/2006
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| 06/06/2006
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| Drug Industry
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| Solvay Pharmaceuticals,
Inc.
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| Table
of Contents
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| Signature:
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| Michael F. Hare
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| EC4
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| 06/13/2006
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| 06/06/2006
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| Drug Industry
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| MedImmune
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| pdf
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| Signature:
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| Kavanaugh, Nancy
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| EC5
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| 06/13/2006
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| 06/07/2006
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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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| Stokley, M.S.P.H., Anne N.
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| EC6
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| 06/13/2006
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| 06/08/2006
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| Health Care Association
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| Infectious Diseases
Society of America
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| pdf
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| Signature:
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| Hantman, Julie
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| EC7
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| 06/13/2006
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| 06/08/2006
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| Drug Industry
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| Sanofi Pasteur
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| pdf
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| Signature:
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| Guito, Ken
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| EMC1
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| 06/23/2006
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| 06/23/2006
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| Federal Government
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| NIAID
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| pdf
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| Signature:
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| Ranjan Gupta, PhD
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Top | Up
Page last updated
January 5, 2007
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