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Showing 1 - 20 results of 278 for search 'U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Center for Biologics Evaluation and Research,', query time: 0.99s Refine Results
  1. 1
    Guidance for industry : providing regulatory submissions in electronic format, prescription drug advertising and promotional labeling.
    Published 2001
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
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    Government Document eBook
  2. 2
    Guidance for industry : S2B genotoxicity, a standard battery for genotoxicity testing of pharmaceuticals.
    Published 1997
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
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    Government Document Conference Proceeding eBook
  3. 3
    Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 5, disintegration test general chapter.
    Published 2008
    “...[Center for Drug Evaluation and Research] ; [U.S. Dept. of Health and Human Services, Food and Drug...”
    Get full text
    Government Document Conference Proceeding eBook
  4. 4
    E2f development safety update report.
    Published 2008
    “...[Center for Drug Evaluation and Research] ; [U.S. Dept. of Health and Human Services, Food and Drug...”
    Get full text
    Government Document Conference Proceeding eBook
  5. 5
    Guidance for industry : indexing structured product labeling.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document eBook
  6. 6
    Guidance for industry : providing regulatory submissions in electronic format, postmarketing indivudal case safety reports.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document eBook
  7. 7
    Guidance for industry : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document eBook
  8. 8
    Guidance for industry : Q3A impurities in new drug substances.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document Conference Proceeding eBook
  9. 9
    Guidance for industry : S1C(R2) dose selection for carcinogenicity studies.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
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    Government Document Conference Proceeding eBook
  10. 10
    Animal models : essential elements to address efficacy under the animal rule.
    Published 2008
    “...[U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document eBook
  11. 11
    Guidance for industry : cooperative manufacturing arrangements for licensed biologics.
    “...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 : M2 eCTD : electronic common technical document specification.
    Published 2003
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document Conference Proceeding eBook
  13. 13
    Guidance for industry M2 : eCTD specification : questions & answers and change requests.
    Published 2005
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document Conference Proceeding eBook
  14. 14
    Guidance for industry : M4, the CTD, efficacy questions and answers.
    Published 2004
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document Conference Proceeding eBook
  15. 15
    Guidance for industry : M4, the CTD, general questions and answers.
    Published 2004
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document Conference Proceeding eBook
  16. 16
    Guidance for industry : submitting marketing applications according to the ICH-CTD format, general considerations.
    Published 2001
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document eBook
  17. 17
    Guidance for industry : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document eBook
  18. 18
    Guidance for industry : providing regulatory submissions in electronic format, receipt date.
    Published 2007
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document eBook
  19. 19
    Guidance for industry : reports on the status of postmarketing study commitments : implementation of section 130 of the Food and Drug Administration Modernization Act of 1997.
    Published 2006
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document eBook
  20. 20
    Guidance for industry : fast track drug development programs, designation, development and application review.
    Published 2006
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document eBook
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