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2005D-0057:
REVIEWER GUIDANCE ON CONDUCTING A CLINICAL SAFETY REVIEW OF A NEW
PRODUCT APPLICATION AND PREPARING A REPORT ON THE REVIEW; AVAILABILITY
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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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| 02/18/2005
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| 02/18/2005
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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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| 02/17/2005
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| FDA
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| FDA
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| 02/18/2005
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| 8381-8381
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| 02/20/2006
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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Page last updated
March 15, 2005
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