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  1. 1
    Approved drug products with therapeutic equivalence evaluations.
    Published 1985
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    Government Document Microform Serial
  2. 2
    Quick index to general subjects of interest related to drug regulation.
    Published 1992
    Government Document Serial
  3. 3
    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
    URL accesses index of CDER guidance documents, from which a link may be made to the title desired
    Government Document Microform Book
  4. 4
    Report to industry.
    Published 1997
    Government Document Serial
  5. 5
    CDER ... report to the nation /
    Published 1998
    Archived issues:
    Government Document Serial
  6. 6
    From test tube to patient : improving health through human drugs /
    Published 1999
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    Adobe Acrobat reader required
    Government Document Book
  7. 7
    CDER ... report to the nation : improving public health through human drugs /
    Published 1998
    Archived issues:
    Government Document Serial
  8. 8
    Annual performance report, Prescription Drug User Fee Act of 1992 fiscal year : ... report to Congress /
    Published 1997
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    Government Document Serial
  9. 9
    FY ... performance report to Congress for the Prescription Drug User Fee Act of 1992 as amended by the Food and Drug Administration Modernization Act of 1997 /
    Published 1998
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    Government Document Serial
  10. 10
    Drugs@FDA.
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    Government Document eBook
  11. 11
    Annual adverse drug experience report.
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    Government Document Serial
  12. 12
    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
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    Government Document eBook
  13. 13
    Guidance for industry : CGMP for phase 1 investigational drugs.
    Published 2008
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    Government Document eBook
  14. 14
    Guidance for industry : indexing structured product labeling.
    Published 2008
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    Government Document eBook
  15. 15
    Guidance for industry : Q3A impurities in new drug substances.
    Published 2008
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    Government Document Conference Proceeding eBook
  16. 16
    Guidance for industry : S1C(R2) dose selection for carcinogenicity studies.
    Published 2008
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    Government Document Conference Proceeding eBook
  17. 17
    Animal models : essential elements to address efficacy under the animal rule.
    Published 2008
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    Government Document eBook
  18. 18
    Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.
    Published 2008
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    Government Document Conference Proceeding eBook
  19. 19
    Guidance for indusry : integrated summary of effectiveness.
    Published 2008
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    Government Document eBook
  20. 20
    Frecuentes preguntas acerca de las drogas genéricas.
    Published 2004
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    Government Document Book
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