Showing 1 - 20 results of 313 for search 'Center for Biologics Evaluation and Research (U.S.)', query time: 0.19s Refine Results
  1. 1
    Annual report /
    “...Center for Biologics Evaluation and Research (U.S.)...”
    latest issue only
    Government Document Microform Serial
  2. 2
    Evolving scientific and regulatory perspectives on cell substrates for vaccine development : Double Tree Hotel, Rockville, Maryland, USA, September 7-10, 1999 /
    Published 2001
    “...Center for Biologics Evaluation and Research (U.S.)...”
    Book
  3. 3
    Report to the biologics community /
    “...Center for Biologics Evaluation and Research (U.S.)...”
    Latest issue
    Government Document Microform Serial
  4. 4
    Report to the biologics community /
    “...Center for Biologics Evaluation and Research (U.S.)...”
    Get full text
    Government Document Microform Serial
  5. 5
    Guidance for industry : clinical data needed to support the licensure of pandemic influenza vaccines.
    Published 2007
    “...Center for Biologics Evaluation and Research (U.S.)...”
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    Government Document eBook
  6. 6
    Guidance for industry : clinical data needed to support the licensure of seasonal inactivated influenza vaccines.
    Published 2007
    “...Center for Biologics Evaluation and Research (U.S.)...”
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    Government Document eBook
  7. 7
    Guidance for industry : nucleic acid testing (NAT) to reduce the possible risk of parvovirus B19 transmission by plasma-derived products.
    Published 2008
    “...Center for Biologics Evaluation and Research (U.S.)...”
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    Government Document eBook
  8. 8
    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
    “...Center for Biologics Evaluation and Research (U.S.)...”
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    Government Document eBook
  9. 9
    Guidance for industry : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications.
    Published 2008
    “...Center for Biologics Evaluation and Research (U.S.)...”
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    Government Document eBook
  10. 10
    Guidance for industry : general principles for the development of vaccines to protect against global infectious diseases.
    Published 2008
    “...Center for Biologics Evaluation and Research (U.S.)...”
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    Government Document eBook
  11. 11
    Guidance for FDA reviewers : premarket notification submissions for empty containers for the collection and processing of blood and blood components.
    Published 2001
    “...Center for Biologics Evaluation and Research (U.S.)...”
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    Government Document eBook
  12. 12
    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
    “...Center for Biologics Evaluation and Research (U.S.)...”
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    Government Document eBook
  13. 13
    Guidance for industry : recommendations for collecting red blood cells by automated apheresis methods.
    Published 2001
    “...Center for Biologics Evaluation and Research (U.S.)...”
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    Government Document eBook
  14. 14
    Guidance for industry : pre-storage leukocyte reduction of whole blood and blood compoments intended for transfusion.
    Published 2001
    “...Center for Biologics Evaluation and Research (U.S.)...”
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    Government Document eBook
  15. 15
    PHS guideline on infectious disease issues in xenotransplantation.
    Published 2001
    “...Center for Biologics Evaluation and Research (U.S.)...”
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    Government Document eBook
  16. 16
    Guidance for industry : use of sterile connecting devices in blood bank practices.
    Published 2000
    “...Center for Biologics Evaluation and Research (U.S.)...”
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    Government Document eBook
  17. 17
    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
    “...Center for Biologics Evaluation and Research (U.S.)...”
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    Government Document eBook
  18. 18
    Guidance for industry : potency tests for cellular and gene therapy products.
    Published 2008
    “...Center for Biologics Evaluation and Research (U.S.)...”
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    Government Document eBook
  19. 19
    PDUFA pilot project : proprietary name review.
    Published 2008
    “...Center for Biologics Evaluation and Research (U.S.)...”
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    Government Document eBook
  20. 20
    Guidance for industry : how to comply with the Pediatric Research Equity Act.
    Published 2005
    “...Center for Biologics Evaluation and Research (U.S.)...”
    Get full text
    Government Document eBook
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