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Showing 1 - 20 results of 297 for search 'Dept. of Health and Human Services,', query time: 0.45s Refine Results
  1. 1
    FY ... performance report to Congress for the Prescription Drug User Fee Act of 1992 as amended by the Food and Drug Administration Modernization Act of 1997 /
    Published 1998
    “...Food and Drug Administration, Dept. of Health and Human Services,...”
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    Government Document Serial
  2. 2
    Annual performance report, Prescription Drug User Fee Act of 1992 fiscal year : ... report to Congress /
    Published 1997
    “...Food and Drug Administration, Public Health Service, Dept. of Health and Human Services,...”
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    Government Document Serial
  3. 3
    Information sheet : guidance for institutional review boards and clinical investigators (non-local IRB review).
    Published 1998
    “...[U.S. Dept. of Health and Human Services, Food and Drug Administration],...”
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    Government Document eBook
  4. 4
    Proceedings of the Sixth International Symposium on Pertussis /
    Published 1990
    “...Dept. of Health and Human Services, U.S. Public Health Service, Food and Drug Administration,...”
    Government Document Conference Proceeding Microform Book
  5. 5
    Information sheet guidance for IRBs, clinical investigators, and sponsors : frequently asked questions about medical devices.
    Published 2006
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices...”
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    Government Document eBook
  6. 6
    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
  7. 7
    Guidance for industry : clinical studies section of labeling for human prescription drug and biological products, content and format.
    Published 2006
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation,...”
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    Government Document eBook
  8. 8
    A review of FDA's implementation of the Drug Export Amendments of 1986.
    Published 1990
    “...U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration...”
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    Government Document eBook
  9. 9
    Guidance for industry : clinical data needed to support the licensure of pandemic influenza vaccines.
    Published 2007
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
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    Government Document eBook
  10. 10
    Guidance for industry : clinical data needed to support the licensure of seasonal inactivated influenza vaccines.
    Published 2007
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
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    Government Document eBook
  11. 11
    Guidance for industry : nucleic acid testing (NAT) to reduce the possible risk of parvovirus B19 transmission by plasma-derived products.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
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    Government Document eBook
  12. 12
    Guidance for industry : safety, efficacy, and pharmacokinetic studies to support marketing of immune globuline intravenous (human) as replacement therapy for primary humoral immunodeficiency.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
    Get full text
    Government Document eBook
  13. 13
    Guidance for industry : general principles for the development of vaccines to protect against global infectious diseases.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
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    Government Document eBook
  14. 14
    Guidance for FDA reviewers : premarket notification submissions for empty containers for the collection and processing of blood and blood components.
    Published 2001
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
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    Government Document eBook
  15. 15
    Guidance for industry : revised recommendations regarding invalidation of test results of licensed and 510(k) cleared bloodborne pathogen assays used to test donors.
    Published 2001
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
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    Government Document eBook
  16. 16
    Guidance for industry : recommendations for collecting red blood cells by automated apheresis methods.
    Published 2001
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
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    Government Document eBook
  17. 17
    Guidance for industry : pre-storage leukocyte reduction of whole blood and blood compoments intended for transfusion.
    Published 2001
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
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    Government Document eBook
  18. 18
    Guidance for industry : use of sterile connecting devices in blood bank practices.
    Published 2000
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
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    Government Document eBook
  19. 19
    Guidance for industry : Current Good Tissue Practice (CGTP) and additional requirements for manufacturers of human cells, tissues, and cellular and tissue based products (HCT/Ps).
    Published 2009
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
    Get full text
    Government Document eBook
  20. 20
    Guidance for industry : potency tests for cellular and gene therapy products.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
    Get full text
    Government Document eBook
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