Showing 1 - 20 results of 304 for search 'The Center.', query time: 0.44s Refine Results
  1. 1
    Annual report /
    “...The Center....”
    latest issue only
    Government Document Microform Serial
  2. 2
    Guidance for industry : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.
    Published 1995
    “...Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research,...”
    URL accesses index of CDER guidance documents, from which a link may be made to the title desired
    Government Document Microform Book
  3. 3
    Guideline for industry : detection of toxicity to reproduction for medicinal products, addendum on toxicity to male fertility.
    Published 1996
    “...[Center for Drug Evaluation and Research] : [Center for Biologics Evaluation and Research],...”
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    Government Document Conference Proceeding eBook
  4. 4
    Revision of the ICH guideline on clinical safety data management : data elements for transmission of individual case safety reports.
    Published 2005
    “...[Center for Drug Evaluation and Research] : [Center for Biologics Evaluation and Research],...”
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    Government Document Conference Proceeding eBook
  5. 5
    Guidance for industry : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.
    Published 1995
    “...Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research,...”
    Get full text
    Government Document eBook
  6. 6
    Report to the biologics community /
    “...Center for Biologics Evaluation and Research....”
    Latest issue
    Government Document Microform Serial
  7. 7
    Report to the biologics community /
    “...Center for Biologics Evaluation and Research....”
    Get full text
    Government Document Microform Serial
  8. 8
    Guidance for industry : FDA export certificates.
    Published 2005
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
    Get full text
    Government Document eBook
  9. 9
    Guidance for industry : providing regulatory submissions in electronic format, general considerations.
    Published 2003
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
    Get full text
    Government Document eBook
  10. 10
    Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products.
    Published 2008
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
    Get full text
    Government Document eBook
  11. 11
    Guidance for industry : computerized systems used in clinical trials.
    Published 1999
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
    Get full text
    Government Document eBook
  12. 12
    Guidance for industry : pharmacogenomic data submissions, companion evidence.
    Published 2007
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document eBook
  13. 13
    Guidance for industry : part 11, electronic records : electronic signatures--scope and application.
    Published 2003
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation...”
    Get full text
    Government Document eBook
  14. 14
    Guidance for industry : 21 CFR, part 11, electronic records : electronic signatures, glossary of terms.
    Published 2001
    “... : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center...”
    Get full text
    Government Document eBook
  15. 15
    Guidance for industry : 21 CFR part 11, electronic records, electronic signatures, validation.
    Published 2001
    “... : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center...”
    Get full text
    Government Document eBook
  16. 16
    Guidance for industry : 21 CFR, part 11, electronic records : electronic signatures, electronic copies of electronic records.
    Published 2002
    “... : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center...”
    Get full text
    Government Document eBook
  17. 17
    Guidance for industry : complementary and alternative medicine products and their regulation by the Food and Drug Administration.
    Published 2006
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
    Get full text
    Government Document eBook
  18. 18
    Demonstration of comparability of human biological products, including therapeutic biotechnology-derived products.
    Published 1996
    “...U.S. Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug...”
    Get full text
    Government Document eBook
  19. 19
    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
    “...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 : comparability protocols, protein drug products and biological products; chemistry, manufacturing, and controls information.
    Published 2003
    “...U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics...”
    Get full text
    Government Document eBook
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