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2005D-0056:
GUIDANCE FOR INDUSTRY: RECOMMENDATIONS FOR OBTAINING A LABELING
CLAIM FOR COMMUNICABLE DISEASE DONOR SCREENING TESTS USING CADAVERIC
BLOOD SPECIMENS FROM DONORS OF HUMAN CELLS, TISSUES, AND CELLULAR
AND TISSUE-BASED PRODUCTS (HCT/PS)
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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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| BKG1
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| 02/23/2005
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| 02/23/2005
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| Federal
Government
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| Background Material
Refs 1 - 5 70FR9083
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| TOC
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| Signature:
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| Background Material
Refs 1 - 5 70FR
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| GDL1
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| 02/23/2005
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| 02/23/2005
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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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| 02/23/2005
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| FDA
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| FDA
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| 02/24/2005
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| 9083-9084
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| C1
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| 04/20/2005
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| 04/19/2005
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| Association
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| American
Society for Reproductive Medicine (ASRM) and Society for Assisted
Reproductive Tech (SART)
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| pdf
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| Signature:
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| Robert W. Rebar, MD
and Eric Surrey,
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Page last updated
May 6, 2005
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