Showing 1 - 20 results of 302 for search '', query time: 0.20s Refine Results
  1. 1
    Guidance for industry : clinical data needed to support the licensure of pandemic influenza vaccines.
    Published 2007
    Get full text
    Government Document eBook
  2. 2
    Guidance for industry : clinical data needed to support the licensure of seasonal inactivated influenza vaccines.
    Published 2007
    Get full text
    Government Document eBook
  3. 3
    Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 5, disintegration test general chapter.
    Published 2008
    Get full text
    Government Document Conference Proceeding eBook
  4. 4
    E2f development safety update report.
    Published 2008
    Get full text
    Government Document Conference Proceeding eBook
  5. 5
    Guidance for industry : submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes.
    Published 2008
    Get full text
    Government Document eBook
  6. 6
    Guidance for industry : nucleic acid testing (NAT) to reduce the possible risk of parvovirus B19 transmission by plasma-derived products.
    Published 2008
    Get full text
    Government Document eBook
  7. 7
    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
    Get full text
    Government Document eBook
  8. 8
    Guidance for industry : CGMP for phase 1 investigational drugs.
    Published 2008
    Get full text
    Government Document eBook
  9. 9
    Guidance for industry : indexing structured product labeling.
    Published 2008
    Get full text
    Government Document eBook
  10. 10
    Guidance for industry : providing regulatory submissions in electronic format, postmarketing indivudal case safety reports.
    Published 2008
    Get full text
    Government Document eBook
  11. 11
    Guidance for industry : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications.
    Published 2008
    Get full text
    Government Document eBook
  12. 12
    Guidance for industry : Q3A impurities in new drug substances.
    Published 2008
    Get full text
    Government Document Conference Proceeding eBook
  13. 13
    Guidance for industry : S1C(R2) dose selection for carcinogenicity studies.
    Published 2008
    Get full text
    Government Document Conference Proceeding eBook
  14. 14
    Animal models : essential elements to address efficacy under the animal rule.
    Published 2008
    Get full text
    Government Document eBook
  15. 15
    Guidance for industry : general principles for the development of vaccines to protect against global infectious diseases.
    Published 2008
    Get full text
    Government Document eBook
  16. 16
    Guidance for indusry : integrated summary of effectiveness.
    Published 2008
    Get full text
    Government Document eBook
  17. 17
    Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff : humanitarian device exemption regulation, questions and answers.
    Published 2008
    Get full text
    Government Document eBook
  18. 18
    Guidance for FDA reviewers : premarket notification submissions for empty containers for the collection and processing of blood and blood components.
    Published 2001
    Get full text
    Government Document eBook
  19. 19
    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
    Get full text
    Government Document eBook
  20. 20
    Guidance for industry : recommendations for collecting red blood cells by automated apheresis methods.
    Published 2001
    Get full text
    Government Document eBook
Search Tools: RSS Feed – Email Search