Showing 1 - 20 results of 46 for search '"Biology"', query time: 0.29s Refine Results
  1. 1
    Report to the biologics community /
    Subjects: “...Center for Biologics Evaluation and Research (U.S.) Periodicals....”
    Latest issue
    Government Document Microform Serial
  2. 2
    Guidance for industry and FDA staff : commercially distributed analyte specific reagents (ASRs), frequently asked questions.
    Published 2007
    Subjects: “...Biological reagents....”
    Get full text
    Government Document eBook
  3. 3
    Report to the biologics community /
    Subjects: “...Center for Biologics Evaluation and Research (U.S.) Periodicals....”
    Get full text
    Government Document Microform Serial
  4. 4
    Guidance for industry : cooperative manufacturing arrangements for licensed biologics.
    Subjects: “...Biologicals....”
    Get full text
    Government Document eBook
  5. 5
    Guidance for industry : considerations for allogeneic pancreatic islet cell products.
    Published 2008
    Subjects: “...Biologicals....”
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    Government Document eBook
  6. 6
    Demonstration of comparability of human biological products, including therapeutic biotechnology-derived products.
    Published 1996
    Subjects: “...Biologicals United States....”
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    Government Document eBook
  7. 7
    Guidance for industry : indexing structured product labeling.
    Published 2008
    Subjects: “...Biologicals Labeling....”
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    Government Document eBook
  8. 8
    Guidance for indusry : integrated summary of effectiveness.
    Published 2008
    Subjects: “...Biologicals Effectiveness....”
    Get full text
    Government Document eBook
  9. 9
    Guidance for industry : providing regulatory submissions to the Center for Biologics Evaluation and Research (CBER) in electronic format, lot release protocols.
    Published 2007
    Subjects: “...Biologicals Testing....”
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    Government Document eBook
  10. 10
    Guidance for industry and review staff : labeling for human prescription drug and biological products : determining established pharmacologic class for use in the highlights of prescribing information.
    Published 2009
    Subjects: “...Biologicals Labeling....”
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    Government Document eBook
  11. 11
    Guidance for industry : labeling for human prescription drug and biological products, implementing the new content and format requirements.
    Published 2006
    Subjects: “...Biologicals Labeling....”
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    Government Document eBook
  12. 12
    Guidance for industry : biological product deviation reporting for licensed manufacturers of biological products other than blood and blood components.
    Published 2006
    Subjects: “...Biological products Government policy United States....”
    Get full text
    Government Document eBook
  13. 13
    Guidance for industry : dosage and administration section of labeling for human prescription drug and biological products, content and format.
    Published 2007
    Subjects: “...Biologicals Labeling....”
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    Government Document eBook
  14. 14
    Guidance for industry : process validation, general principles and practices.
    Published 2008
    Subjects: “...Biologicals Evaluation....”
    Get full text
    Government Document eBook
  15. 15
    Guidance for industry : Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.
    Published 1998
    Subjects: “...Biological products Evaluation....”
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    Government Document Conference Proceeding eBook
  16. 16
    Guidance for industry : providing clinical evidence of effectiveness for human drug and biological products.
    Published 1998
    Subjects: “...Biologicals United States....”
    Get full text
    Government Document eBook
  17. 17
    Guidance for industry : integrated summaries of effectiveness and safety : location within the common technical document.
    Published 2009
    Subjects: “...Biologicals Effectiveness United States....”
    Get full text
    Government Document eBook
  18. 18
    Guidance for industry : Q6B specifications : test procedures and acceptance criteria for biotechnological /biological products.
    Published 1999
    Subjects: “...Biological products Testing....”
    Get full text
    Government Document Conference Proceeding eBook
  19. 19
    Guidance for industry : monoclonal antibodies used as reagents in drug manufacturing.
    Published 2001
    Subjects: “...Biological reagents....”
    Get full text
    Government Document eBook
  20. 20
    Guidance for industry : clinical pharmacology section of labeling for human prescription drug and biological products : content and format.
    Published 2009
    Subjects: “...Biological products Labeling United States....”
    Get full text
    Government Document eBook
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