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Showing 1 - 9 results of 9 for search 'U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products,', query time: 0.39s Refine Results
  1. 1
    Guidance for industry and FDA staff : submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product.
    Published 2004
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination...”
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    Government Document eBook
  2. 2
    Guidance for industry and FDA staff : devices used to process human cells, tissues, and cellular and tissue-based products (HCT/Ps).
    Published 2007
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner...”
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    Government Document eBook
  3. 3
    Guidance for industry and FDA staff : early development considerations for innovative combination products.
    Published 2006
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner...”
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    Government Document eBook
  4. 4
    Guidance for industry and FDA : current good manufacturing practice for combination products.
    Published 2004
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner...”
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    Government Document eBook
  5. 5
    Guidance for industry and FDA staff : how to write a request for designation (RFD).
    Published 2005
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner...”
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    Government Document eBook
  6. 6
    Guidance for industry and FDA staff : application user fees for combination products.
    Published 2005
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner...”
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    Government Document eBook
  7. 7
    Guidance for industry and staff : minimal manipulation of structural tissue jurisdictional update.
    Published 2006
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner...”
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    Government Document eBook
  8. 8
    Guidance for industry : new contrast imaging indication considerations for devices and approved drug and biological products.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination...”
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    Government Document eBook
  9. 9
    Draft guidance for industry and FDA staff : technical considerations for pen, jet, and related injectors intended for use with drugs and biological products.
    Published 2009
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices...”
    Get full text
    Government Document eBook
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