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2005D-0047:
GUIDANCE FOR INDUSTRY: CONSIDERATIONS FOR PLASMID DNA VACCINES FOR
INFECTIOUS DISEASE INDICATIONS
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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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| 03/01/2005
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| 03/01/2005
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| Federal
Government
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| GUIDANCE
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| pdf
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| NAD1
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| 02/17/2005
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| FDA
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| FDA
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| 02/18/2005
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| 8378-8379
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| 05/19/2005
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| BKG1
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| 02/18/2005
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| 02/18/2005
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| Federal Government
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| Background Information
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| Table
of Contents
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| Signature:
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| Background Information
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| C1
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| 05/19/2005
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| 05/18/2005
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| Drug Industry
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| Wyeth Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Susan J. Sciotto-Brown and Jack
D. L
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| C2
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| 05/19/2005
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| 05/16/2005
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| Consumer Group
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| AIDS Vaccine Advocacy
Coalition (AVAC)
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| pdf
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| Signature:
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| Mitchell Warren and Robert Reinhard
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| EMC1
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| 05/14/2005
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| 05/14/2005
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| Association
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| AIDS Vaccine Advocacy
Coalition (AVAC)
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| pdf
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| Signature:
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| Mitchell Warren and Robert Reinhard
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| EMC2
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| 05/19/2005
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| 05/19/2005
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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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| Amy P. Patterson, M.D.
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| EMC3
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| 05/19/2005
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| 05/19/2005
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| Drug Industry
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| Merck & Co., Inc.
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| pdf
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| Signature:
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| Taryn Rogalski-Salter, PhD
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| C3
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| 05/20/2005
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| 05/19/2005
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| Private Industry
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| Vical Incorporated
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| pdf
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| Signature:
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| William H. Cover, PhD
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| EC1
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| 05/26/2005
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| 05/18/2005
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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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| EC2
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| 05/26/2005
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| 05/19/2005
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| Drug Industry
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| Vical Incorporated
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| Attachments: 1,
2
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| Signature:
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| Cover, William
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| C4
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| 05/25/2005
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| 05/24/2005
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| Private Industry
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| GlaxoSmithKline
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| pdf
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| Signature:
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| Mary Faye S Whisler PhD
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| C5
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| 06/13/2005
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| 06/13/2005
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| Private Industry
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| Vaccines Research
Advocate
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| pdf
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| Signature:
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| Jesse Creel
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| C6
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| 09/14/2006
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| 09/11/2006
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| Drug Industry
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| Scarab Genomics,
LLC
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| pdf,
Copyrighted Material
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| Signature:
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| Frederick Blattner, PhD
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| C7
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| 10/11/2006
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| 10/06/2006
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| Private
Industry
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| Scarab Genomics
LLC
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| pdf,
Copyrighted Material
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| Signature:
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| John Campbell PhD for Frederick
Blat
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| REF1
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| 10/26/2007
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| 10/26/2007
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| Federal
Government
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| Reference
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| pdf
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| Signature:
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| Reference
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| GDL2
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| 10/26/2007
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| 10/26/2007
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| Federal
Government
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| Guidance for
Industry
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| pdf
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| Signature:
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| Guidance for Industry
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| NAD2
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| 10/26/2007
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| FDA
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| FDA
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| 10/29/2007
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| 61172-61172
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| [TXT] [PDF]
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| Signature:
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| SHUREN, JEFFREY
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Page last updated
November 2, 2007
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