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  • 1.  CDER SEND datasets for new IND

    This message was posted by a user wishing to remain anonymous
    Posted 25-Feb-2021 17:13
    This message was posted by a user wishing to remain anonymous

    Hi all - can anyone provide some insights as to recent experience with SEND datasets when opening a new IND with CDER?

    I am used to either providing the SEND data sets as part of the initial submission or have it ready when the SEND data is requested duriing the 30 day review.  However I have also become aware that it may be possible to submit and have the IND reviewed without the SEND datasets, and submit the SEND datasets within the 120 day period with the final tox reports.


  • 2.  RE: CDER SEND datasets for new IND

    This message was posted by a user wishing to remain anonymous
    Posted 26-Feb-2021 08:55
    This message was posted by a user wishing to remain anonymous

    FDA has required in the last several IND's I have done across several divisions that SEND for the tox reports for GLP and non GLP studies be submitted. You would want an agreement ahead of time to submit SEND within the 120 day period. I Believe they were trying to automate it to check for it within the eCTD but I could be wrong - ?
    Original Message


  • 3.  RE: CDER SEND datasets for new IND

    Posted 27-Feb-2021 09:07
    I think you may be confusing the FDA guidance that allows for unaudited draft reports to be submitted in the IND as long as the final audited report is submitted within 120 days from the start of the human clinical study for Phase 1 studies with SEND dataset submission. That being said if submitting unaudited tox report in IND in order to start PHASE 1 clinical study then likely audited SEND dataset is not available.

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    Robert Blanks RAC
    VP, Regulatory Affairs and Quality Assurance
    [Ardelyx]
    Auburndale MA
    United States
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    Original Message


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