Showing 1 - 20 results of 313 for search 'Center for Biologics Evaluation and Research (U.S.)', query time: 0.28s 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.)...”
    Get full text
    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.)...”
    Get full text
    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.)...”
    Get full text
    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.)...”
    Get full text
    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.)...”
    Get full text
    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.)...”
    Get full text
    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.)...”
    Get full text
    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.)...”
    Get full text
    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.)...”
    Get full text
    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.)...”
    Get full text
    Government Document eBook
  15. 15
    PHS guideline on infectious disease issues in xenotransplantation.
    Published 2001
    “...Center for Biologics Evaluation and Research (U.S.)...”
    Get full text
    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.)...”
    Get full text
    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.)...”
    Get full text
    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.)...”
    Get full text
    Government Document eBook
  19. 19
    PDUFA pilot project : proprietary name review.
    Published 2008
    “...Center for Biologics Evaluation and Research (U.S.)...”
    Get full text
    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
Search Tools: RSS Feed – Email Search