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2004D-0465:
GUIDANCE FOR FDA REVIEW STAFF AND SPONSORS: CONTENT AND REVIEW OF
CHEMISTRY, MANUFACTURING, AND CONTROL (CMC) INFORMATION FOR HUMAN
GENE THERAPY INVESTIGATIONAL NEW DRUG APPLICATIONS (INDS)
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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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| Volume
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| Remarks
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| GDL1
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| 11/09/2004
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| 11/09/2004
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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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| 11/08/2004
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| FDA
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| FDA
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| 11/09/2004
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| 64958-64959
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| 02/07/2005
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| EXT1
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| 02/07/2005
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| 02/07/2005
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| Drug Industry
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| Merck Research Laboratories
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| txt
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| Signature:
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| Brian Mayhew
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| C1
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| 02/10/2005
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| 02/07/2005
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| Drug Industry
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| Targeted Genetics
Corporation (TGC)
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| pdf
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| Signature:
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| Rae Saltzstein
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| EMC1
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| 02/14/2005
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| 02/14/2005
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| Drug Industry
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| Merck & Co., Inc.
(Merck)
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| pdf
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| Signature:
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| Brian Mayhew
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Top
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Page last updated
March 3, 2005
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