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  1. 1
    Purple Book Continuity Act of 2019 : report (to accompany H.R. 1520) (including cost estimate of the Congressional Budget Office).
    Published 2019
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    Government Document eBook
  2. 2
    FDA User Fee Agreements : Improving Medical Product Regulation and Innovation for Patients.
    Published 2017
    electronic resource (pdf)
    electronic resource (pdf)
    Government Document eBook
  3. 3
    FDA fast track and priority review programs /
    by Thaul, Susan
    Published 2018
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    Government Document Database
  4. 4
    Improving predictability and transparency in DEA and FDA regulation : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, second session, April 7, 2014.
    Published 2015
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    Government Document eBook
  5. 5
    Guidance for industry : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications.
    Published 2008
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    Government Document eBook
  6. 6
    Access to unapproved drugs : FDA policies on compassionate use and emergency use authorization /
    by Thaul, Susan
    Published 2018
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    Government Document Database
  7. 7
    Animal drug user fee agreements : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Thirteenth Congress, first session, on examining animal drug user fee agreements, focusing on advancing animal health for the public health, February 27, 2013.
    Published 2014
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  8. 8
    Guidance for industry : environmental assessment of human drug and biologics applications.
    Published 1998
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    Government Document eBook
  9. 9
    Guidance for industry : INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information.
    Published 2003
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    Government Document eBook
  10. 10
    Guidance for industry : format and content for the CMC section of an annual report.
    Published 1994
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    Government Document eBook
  11. 11
    Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes.
    Published 2004
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    Government Document eBook
  12. 12
    Guidance for industry : changes to an approved NDA or ANDA, questions and answers.
    Published 2001
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    Government Document eBook
  13. 13
    Guidance for industry : comparability protocols, chemistry, manufacturing, and controls information.
    Published 2003
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    Government Document eBook
  14. 14
    Guidance for industry : botanical drug products.
    Published 2004
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    Government Document eBook
  15. 15
    Guidance for industry : changes to an approved application for specified biotechnology and specified synthetic biological products.
    Published 1997
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    Government Document eBook
  16. 16
    Guidance for industry for the submission documentation for sterilization process validation in applications for human and veterinary drug products.
    Published 1994
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    Government Document eBook
  17. 17
    Guidance for industry : submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes.
    Published 2010
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    Government Document eBook
  18. 18
    Compassionate use and emergency use authorization for unapproved drugs : FDA policies and background /
    Published 2016
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  19. 19
    Guidance for industry : IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information.
    Published 2001
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    Government Document eBook
  20. 20
    Amending the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs : report (to accompany H.R. 1407) (including cost estimate of the Congressional Budget Office).
    Published 2013
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