Showing 41 - 60 results of 111 for search '"Drug Approval United States"', query time: 0.65s Refine Results
  1. 41
    E 16 genomic biomarkers related to drug response : context, structure, and format of qualification submissions.
    Published 2009
    Subjects: “...Drug approval United States....”
    Get full text
    Government Document eBook
  2. 42
    CDER ... report to the nation : improving public health through human drugs /
    Published 1998
    Subjects: “...Drug approval United States Periodicals....”
    Archived issues:
    Government Document Serial
  3. 43
    Center for Drug Evaluation and Research update.
    Subjects: “...Drug approval United States Periodicals....”
    Get full text
    Government Document Serial
  4. 44
    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
    Subjects: “...Drug approval United States....”
    Get full text
    Government Document eBook
  5. 45
    Guidance for industry : format and content for the CMC section of an annual report.
    Published 1994
    Subjects: “...Drug approval United States Government policy....”
    Get full text
    Government Document eBook
  6. 46
    New drug development : science, business, regulatory, and intellectual property issues cited as hampering drug development efforts : report to congressional requesters.
    Published 2006
    Subjects: “...Drug approval United States....”
    Abstract:
    PDF version:
    Government Document eBook
  7. 47
    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
    Subjects: “...Drug approval United States....”
    Get full text
    Government Document eBook
  8. 48
    Guidance for industry : listed drugs, 30 month stays, and approval of ANDAs and 505(b)(2) applications under Hatch-Waxman, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, questions and answers.
    Published 2004
    Subjects: “...Drug approval United States....”
    Get full text
    Government Document eBook
  9. 49
    Guidance for industry : IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information.
    Published 2001
    Subjects: “...Drug approval United States....”
    Get full text
    Government Document eBook
  10. 50
    New drug approval : FDA's consideration of evidence from certain clinical trials : report to congressional requesters.
    Published 2010
    Subjects: “...Drug approval United States....”
    Get full text
    Government Document eBook
  11. 51
    FDA user fee agreements : strengthening FDA and the medical products industry for the benefit of patients : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, second session ... March 29, 2012.
    Published 2014
    Subjects: “...Drug approval United States....”
    Get full text
    Get full text
    Government Document eBook
  12. 52
    Preparing for FDA pre-approval inspections /
    Published 1999
    Subjects: “...Drug Approval United States....”
    Book
  13. 53
    FDA user fee agreements: advancing medical product regulation and innovation for the benefit of patients, FDA center directors : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Seventeenth Congress, second session on examining Food and Drug Administration user fee agreements, focusing on advancing medical product regulation and innovation for the benefit of patients and Food and Drug Administration center directors, April 26, 2022.
    Published 2023
    Subjects: “...Drug approval United States....”
    Get full text
    Government Document eBook
  14. 54
    Guidance for industry : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications.
    Published 2008
    Subjects: “...Drug approval United States....”
    Get full text
    Government Document eBook
  15. 55
    FDA user fees : advancing public health : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, first session ... July 28, 2011.
    Published 2014
    Subjects: “...Drug approval United States....”
    Get full text
    Get full text
    Government Document eBook
  16. 56
    Opioid Review Modernization Act of 2016 : report (to accompany H.R. 4976) (including cost estimate of the Congressional Budget Office).
    Published 2016
    Subjects: “...Drug approval United States....”
    PDF version:
    Text version:
    PDF version:
    Text version:
    Government Document eBook
  17. 57
    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
    Subjects: “...Drug approval United States....”
    PDF version:
    Text version:
    PDF version:
    Text version:
    Government Document eBook
  18. 58
    FDA checkup : drug development and manufacturing challenges : hearing before the Subcommittee on Energy Policy, Health Care and Entitlements of the Committee on Oversight and Government Reform, House of Representatives, One Hundred Thirteenth Congress, first session, December 12, 2013.
    Published 2014
    Subjects: “...Drug approval United States....”
    Get full text
    Get full text
    Government Document eBook
  19. 59
    The Orphan Drug Act and Catalyst Pharmaceuticals, Inc., v. Becerra /
    by Rogers, Hannah-Alise
    Published 2023
    Subjects: “...Drug approval United States....”
    Get full text
    Government Document Database
  20. 60
    Guidance for industry : court decisions, ANDA approvals, and 180-day exclusivity under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act.
    Published 2000
    Subjects: “...Drug approval United States....”
    Get full text
    Government Document eBook
Search Tools: RSS Feed – Email Search