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preclinical SEND datasets in initial IND

  • 1.  preclinical SEND datasets in initial IND

    This message was posted by a user wishing to remain anonymous
    Posted 29-Oct-2020 16:29
    This message was posted by a user wishing to remain anonymous

    Hi, 

    How much experience do you have submitting audited draft reports (ADR) -for the 28 day GLP dog study, for example- without the final SEND and submitting the final SEND within the 120 days from the start of study?  This is mainly a timing issue as it seems standard for vendors to need 6-8 weeks to validate the final SEND from the final reports. 
    • Is it better to submit a final report without the SEND vs an Audited DR?  (chances of any changes to SEND would be lower) 
    • Do you wait until the final reports are done and the final SEND (most conservative)
    • Has FDA been amendable to accepting SEND within the 120 day window of the start of the study? is the review at a disadvantage if all other reports (rat) etc have the data but the last GLP dog study does not?

    I plan to get approval from FDA ahead of time (Oncology division) if we cannot send in the final SEND data with the report, but wanted input on your experience as it's fairly new standard data requirement for preclinical (since 2017).
    Thanks!