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Submitting DSUR in lieu of Annual report

  • 1.  Submitting DSUR in lieu of Annual report

    Posted 26-Jun-2012 09:54
    Hi All,

    I would like to ask the group if anybody have experience submitting a Development Safety Update Report (DSUR) in eCTD format. The current Module 1 does not have a place for DSUR but eventually there will be a place in 1.13.15, so for now we were told to place DSUR in 1.13.3 Summary of Safety Information. I am not clear if submitting a DSUR alone will cover the other sections 1.13.1 - 1.13.14 of an annual report? There are some overlap in the DSUR with the other sections e.g. 1.13.5 Summary of Manufacturing changes can be place as an Appendix to the DSUR. So can DSUR fulfill the requirements of the Annual report to FDA?

    Myleene Consignado
    Senior Regulatory Affairs Associate
    Apopharma Inc.
    Toronto ON