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  1. 1
    New drug development : science, business, regulatory, and intellectual property issues cited as hampering drug development efforts : report to congressional requesters.
    Published 2006
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    Government Document eBook
  2. 2
    El proceso del desarrollo de las drogas y la FDA : cómo la agencia asegura que las drogas sean seguras y efectivas.
    Published 2002
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    Government Document Book
  3. 3
    FDA and the drug development process : how the agency ensures that drugs are safe and effective.
    Published 2002
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    Government Document Book
  4. 4
    Food and Drug Administration's Critical Path Initiative : hearing before a subcommittee of the Committee on Appropriations, United States Senate, One Hundred Tenth Congress, first session, special hearing, June 1, 2007, Salt Lake City, Utah.
    Published 2008
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    Government Document Book
  5. 5
    E2f development safety update report.
    Published 2008
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    Government Document Conference Proceeding eBook
  6. 6
    Information sheet guidance for sponsors, clinical investigators, and IRBs : frequently asked questions, statement of investigator (form FDA 1572).
    Published 2008
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    Government Document eBook
  7. 7
    Guidance for industry : fast track drug development programs, designation, development and application review.
    Published 2006
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    Government Document eBook
  8. 8
    Guidance for industry and FDA staff : early development considerations for innovative combination products.
    Published 2006
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    Government Document eBook
  9. 9
    Guidance for industry : Q3A impurities in new drug substances.
    Published 2008
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    Government Document Conference Proceeding eBook
  10. 10
    Q8(R1) pharmaceutical development revision 1.
    Published 2008
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    Government Document eBook
  11. 11
    Guidance for industry : Q3B(R2) impurities in new drug products.
    Published 2006
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    Government Document Conference Proceeding eBook
  12. 12
    Guidance for industry : S7A safety pharmacology studies for human pharmaceuticals.
    Published 2001
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    Government Document Conference Proceeding eBook
  13. 13
    Guidance for industry : E2E pharmacovigilance planning.
    Published 2005
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    Government Document Conference Proceeding eBook
  14. 14
    Guidance for industry : community-acquired bacterial pneumonia : developing drugs for treatment.
    Published 2009
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    Government Document eBook
  15. 15
    Guidance for industry : influenza, developing drugs for treatment and/or prophylaxis.
    Published 2009
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    Government Document eBook
  16. 16
    Follow-on biologics : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining Food and Drug Administration follow-on biologics, generally referred to as a biotechnology-derived protein drug (or biologic) that is comparable to a novel, previously approved biologic and that is approved with less supporting data than the innovator biologic, March 8, 2007.
    Published 2008
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    Government Document eBook
  17. 17
    Guidance for industry and FDA : current good manufacturing practice for combination products.
    Published 2004
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    Government Document eBook
  18. 18
    Guidance for industry : premarketing risk assessment.
    Published 2005
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    Government Document eBook
  19. 19
    Guidance for industry : PAT, a framework for innovative pharmaceutical development, manufacturing, and quality assurance.
    Published 2004
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    Government Document eBook
  20. 20
    Guidance for industry : manufacturing, processing, or holding active pharmaceutical ingredients.
    Published 1998
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    Government Document eBook
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