Regulatory Open Forum

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  • 1.  Submitting DSUR in lieu of Annual report

    Posted 26-Jun-2012 09:53
    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

  • 2.  RE:Submitting DSUR in lieu of Annual report

    Posted 27-Jun-2012 12:12
    Hello Myleene

    I know for sure that at least some companies have been told to hang the DSUR on 1.13.3 and they leave the others blank.  But realize they included in section 16  of the DSUR - (Region Specific Information) all the components for the annual report that are not in the body of the DSUR. Also they have asked/notified FDA in advance that they are substituting the DSUR for the annual report.

    Hope this is helpful.

    Carol Bailey RAC
    Director, Regulatory Affairs
    Bothell WA
    United States

  • 3.  RE:Submitting DSUR in lieu of Annual report

    Posted 28-Jun-2012 09:34

    The answer to your question lies in the following FDA response:

    As usual, FDA's Connie Robinson provided the following helpful response:

    Currently for an IND, it would be acceptable to place the DSUR as a single document in 1.13.3 Summary of Safety Information. You should state that the DSUR is being submitted in place of the IND annual report in the cover letter and provide a link to the document if possible.

    If information (other than the granular annual report information) is expected as a part of the DSUR, but the information has its own designated eCTD location, the information should be placed in its own designated eCTD location. For example the IB should be placed in Module and you should provide reference links from the DSUR's Appendix 1 and the DSUR TOC rather than including it as an appendix in the DSUR.

    There is also a mock DSUR for fictional investigational/commercial products on ICH's website.  Please note, p. 36 - Significant Manufacturing Changes - deals with a change that could affect the efficacy/safety of the drug.

    I hope this helps.

    Marilyn Rodriguez
    Associate Director, Global Regulatory CMC
    Basking Ridge NJ
    United States