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

    Published 2005
    Online Access
    Online Access
    Government Document Electronic Conference Proceeding eBook
  4. 4

    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
  5. 5

    Dose-response information to support drug registration

    Published 1994
    Online Access
    Online Access
    Government Document Electronic Conference Proceeding eBook
  6. 6

    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
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  9. 9

    Guidance for industry formal meetings between the FDA and sponsors or applicants.

    Published 2009
    Online Access
    Online Access
    Government Document Electronic eBook
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    Guidance for industry major, minor, and telephone amendments to abbreviated new drug applications.

    Published 2001
    Online Access
    Online Access
    Government Document Electronic eBook
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    Guidance for industry revising and ANDA labeling following revision of the RLD labeling.

    Published 2000
    Online Access
    Online Access
    Government Document Electronic eBook
  15. 15

    Guidance for industry ANDAs, impurities in drug products.

    Published 2005
    Online Access
    Online Access
    Government Document Electronic eBook
  16. 16

    Guidance for industry ANDAs, impurities in drug substances.

    Published 2009
    Online Access
    Online Access
    Government Document Electronic eBook
  17. 17

    Guidelines for submitting samples and analytical data for methods validation

    Published 1987
    Online Access
    Online Access
    Government Document Electronic eBook
  18. 18

    Guidance for industry changes to an approved NDA or ANDA.

    Published 2004
    Online Access
    Online Access
    Government Document Electronic eBook
  19. 19

    Guidance for industry classifying resubmissions in response to action letters.

    Published 1998
    Online Access
    Online Access
    Government Document Electronic eBook
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