Search Results

Suggested Topics within your search.
Refine Results
  1. 1
    Cover Image

    Redirecting innovation in U.S. health care options to decrease spending and increase value / Steven Garber, Susan M. Gates, Emmett B. Keeler, Mary E. Vaiana, Andrew W. Mulcahy, Chr... by Garber, Steven, 1950-, Gates, Susan M., 1968-, Keeler, Emmett B., Vaiana, Mary E., Mulcahy, Andrew W., Lau, Christopher, Kellermann, Arthur

    Published 2014
    Online Access (A-Z Journals and Newspapers)
    Electronic eBook

    Save to List
    Saved in:
  2. 2
    Cover Image

    Food and Drug Amendments of 2022 : report of the Committee on Energy and Commerce (to accompany H.R. 7667)

    Published 2022
    Government Document Book

    Save to List
    Saved in:
  3. 3
    Cover Image

    Subcommittee Markup.

    Published 2019
    Full Text (via ProQuest)
    eBook

    Save to List
    Saved in:
  4. 4
    Cover Image

    Development and approval of combination products : a regulatory perspective / edited by Evan B. Siegel.

    Published 2008
    Full Text (via Wiley)
    eBook

    Save to List
    Saved in:
  5. 5
    Cover Image

    Food and Drug Administration : Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities.

    Published 2002
    Full Text (via ProQuest)
    Government Document eBook

    Save to List
    Saved in:
  6. 6
    Cover Image

    FDA Drug Approval : Application Review Times Largely Reflect FDA Goals.

    Published 2020
    Full Text (via ProQuest)
    Government Document eBook

    Save to List
    Saved in:
  7. 7
    Cover Image

    FDA Drug Approval : Application Review Times Largely Reflect Agency Goals.

    Published 2020
    Full Text (via ProQuest)
    Government Document eBook

    Save to List
    Saved in:
  8. 8
    Cover Image

    Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches : summary of a workshop / Jeffrey Fox, Marilee Shelto...

    Published 2010
    Full Text (via ProQuest)
    eBook

    Save to List
    Saved in:
  9. 9
    Cover Image

    Improving animal health : reauthorization of FDA animal drug user fees : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fifte...

    Published 2020
    Government Document Book

    Save to List
    Saved in:
  10. 10
    Cover Image

    Analytical similarity assessment in biosimilar product development / Shein-Chung Chow. by Chow, Shein-Chung

    Published 2019
    Full Text (via Taylor & Francis)
    eBook

    Save to List
    Saved in:
  11. 11
    Cover Image

    Making better drugs for children with cancer / Committee on Shortening the Time Line for New Cancer Treatments, National Cancer Policy Board ; Peter C. Adamson [and others], editor...

    Published 2005
    Full Text (via ProQuest)
    eBook

    Save to List
    Saved in:
  12. 12
    Cover Image

    Biosimilar drug product development / edited by Laszlo Endrenyi, Paul Jules Declerck, Shein-Chung Chow.

    Published 2017
    Full Text (via Taylor & Francis)
    eBook

    Save to List
    Saved in:
  13. 13
    Cover Image

    Guidance for industry 180-day exclusivity when multiple ANDAs are submitted on the same day.

    Published 2003
    Online Access
    Online Access
    Government Document Electronic eBook

    Save to List
    Saved in:
  14. 14
    Cover Image

    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
    Online Access
    Online Access
    Government Document Electronic eBook

    Save to List
    Saved in:
  15. 15
    Cover Image

    Guidance for industry revising and ANDA labeling following revision of the RLD labeling.

    Published 2000
    Online Access
    Online Access
    Government Document Electronic eBook

    Save to List
    Saved in:
  16. 16
    Cover Image

    Guidance for industry major, minor, and telephone amendments to abbreviated new drug applications.

    Published 2001
    Online Access
    Online Access
    Government Document Electronic eBook

    Save to List
    Saved in:
  17. 17
    Cover Image

    Guidance for industry variations in drug products that may be included in a single ANDA.

    Published 1998
    Online Access
    Online Access
    Government Document Electronic eBook

    Save to List
    Saved in:
  18. 18
    Cover Image

    Guidelines for submitting samples and analytical data for methods validation

    Published 1987
    Online Access
    Online Access
    Government Document Electronic eBook

    Save to List
    Saved in:
  19. 19
    Cover Image

    Guidance for industry M2, eCTD specification, questions & answers and change requests.

    Published 2005
    Online Access
    Online Access
    Government Document Electronic Conference Proceeding eBook

    Save to List
    Saved in:
  20. 20
    Cover Image

    Guidance for industry ANDAs, impurities in drug products.

    Published 2005
    Online Access
    Online Access
    Government Document Electronic eBook

    Save to List
    Saved in:
Search Tools: RSS Feed – Save Search