Search Results - [Dept. of Health and Human Services, Food and Drug Administration],

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  1. 1

    Guidance for industry providing regulatory submissions in electronic format, drug establishment registration and drug listing by United States. Food and Drug Administration. Office of the Commissioner

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, 2009
    Description: 13 pages : digital, PDF file.
    “…U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner,…”
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    Government Document Electronic eBook
  2. 2

    The open public hearing FDA advisory committee meetings by United States. Food and Drug Administration. Office of the Commissioner

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, 2004
    Description: 1 online resource (7 pages)
    “…U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner,…”
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    Government Document Electronic eBook
  3. 3

    Guidance for institutional review boards (IRBs) frequently asked questions, IRB registration by United States. Food and Drug Administration. Office of the Commissioner

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, 2009
    Description: 1 online resource (7 pages)
    “…U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner,…”
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  4. 4

    Guidance for clinical investigators, sponsors, and IRBs adverse event reporting to IRBs : improving human subject protection by United States. Food and Drug Administration. Office of the Commissioner

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, 2009
    Description: 1 online resource (6 pages)
    “…U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner,…”
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  5. 5

    Guidance for industry providing regulatory submissions in electronic format, drug establishment registration and drug listing by United States. Food and Drug Administration. Office of the Commissioner

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, 2008
    Description: 11 pages : digital, PDF file.
    “…U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner,…”
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  6. 6

    Guidance for sponsors, industry, researchers, investigators, and Food and Drug Administration staff certifications to accompany drug, biological product and device applications/sub... by United States. Food and Drug Administration. Office of Policy, United States. Food and Drug Administration. Office of the Commissioner

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Policy : Office of the Commissioner, 2009
    Description: 1 online resource (10 pages)
    “…U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Policy : Office of the Commissioner,…”
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  7. 7

    Guidance for industry Prescription Drug Marketing Act (PDMA) requirements, questions and answers by Center for Drug Evaluation and Research (U.S.), United States. Food and Drug Administration. Office of the Commissioner, United States. Food and Drug Administration. Office of Regulatory Affairs

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Office of the Commissioner : Office of Regulatory Affairs, 2006
    Description: 1 online resource (4 pages)
    “…U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Office of the Commissioner : Office of Regulatory Affairs,…”
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  8. 8

    Guidance for industry collection of race and ethnicity data in clinical trials by Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.), Center for Devices and Radiological Health (U.S.), United States. Food and Drug Administration. Office of the Commissioner

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Center for Devices and Radiological Health : Office of the Commissioner, 2005
    Description: 18 pages : digital, PDF file.
    “…U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Center for Devices and Radiological Health : Office of the Commissioner,…”
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  9. 9

    Guidance for industry standards for securing the drug supply chain : standardized numerical identification for prescription drug packages by United States. Food and Drug Administration. Office of the Commissioner, Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.), United States. Food and Drug Administration. Office of Regulatory Affairs

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner : Center for Drug Evaluation and Research (CDER) : Center for Biologics Evaluation and Research (CBER) : Office of Regulatory Affairs, 2009
    Description: 1 electronic text : HTML file.
    “…U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner : Center for Drug Evaluation and Research (CDER) : Center for Biologics Evaluation and Research (CBER) : Office of Regulatory Affairs,…”
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