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SEND Datasets with initial IND

  • 1.  SEND Datasets with initial IND

    This message was posted by a user wishing to remain anonymous
    Posted 09-Aug-2018 16:51
    This message was posted by a user wishing to remain anonymous

    My understanding is that for commercial INDs, any single-dose, repeat-dose or carci nonclinical studies that started after Dec 17, 2017 have to be in SEND format. Has anyone submitted an initial IND recently and did you include SEND for applicable studies?  Would it be acceptable to submit the initial IND with audited draft report only for certain applicable studies and follow-up with a final report along with SEND within 120-days (per the 2000 Guidance for Industry Q&A for Content and Format of INDs for Phase 1 Studies)?  Also do you interpret the SEND requirement to apply to both GLP and non-GLP studies?

    Thanks!


  • 2.  RE: SEND Datasets with initial IND

    Posted 10-Aug-2018 09:28
    It is my understanding that the requirements for submission of electronic datasets are relevant for NDA, ANDA and BLA and not for INDs, unless requested.  Nonclinical studies with start dates after December 2017 should collect and store the data in SEND format.  Data listings in the PDF report should be in that format.  I interpret the requirement for SEND format to refer only to GLP studies.  If anyone interprets these requirements differently it would be helpful to know it.

    It is still possible to submit the original IND with audited draft reports and submit the final reports at a later time.

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    Glen Park
    Jersey City NJ
    United States
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    Original Message


  • 3.  RE: SEND Datasets with initial IND

    Posted 10-Aug-2018 11:42
    I amend my comment to indicate that SEND datasets should be submitted to the IND with final reports for studies starting after December 17, 2017.

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    Glen Park
    Jersey City NJ
    United States
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    Original Message


  • 4.  RE: SEND Datasets with initial IND

    Posted 13-Aug-2018 09:35
    Hi Anonymous,

    We are currently submitting our commercial INDs with the accompanying SEND datasets.  I agree with your interpretation that the SEND datasets are required for single-dose tox, repeat-dose tox, and carc studies.  In the issue of whether non-GLP studies will require SEND datasets, we are currently taking a conservative approach and any study report submitted within Module 4 sections 4.2.3.1, 4.2.3.2, or 4.2.3.4 that had a start date after the December 2017 deadline should have the appropriate accompanying SEND dataset. If/when we have a client that would like to submit the draft report with the IND and follow up with the final report and SEND dataset, we would obtain FDA approval from the RPM that the approach is sound; that decision is likely specific to the program and what other studies will be included for FDA review and/or the review division.

    Feel free to contact me if you'd like to discuss my interpretation of SEND in more detail.

    Kaitlyn

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    Kaitlyn Riffel
    Cardinal Health Regulatory Sciences
    Kansas City MO
    United States
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    Original Message


  • 5.  RE: SEND Datasets with initial IND

    Posted 29-Oct-2020 14:30
    For an initial IND, Can an audited draft report  (for a GLP dog study) be sent in and the final report and final SEND be sent within the 120 days? Or as a further assurance, can a final report be sent in with the SEND to follow within the 120 days ? Would you get pre approval from the division on doing this? Thank you!

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    Norma Ascroft
    Lake Forest IL
    United States
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    Original Message


  • 6.  RE: SEND Datasets with initial IND

    This message was posted by a user wishing to remain anonymous
    Posted 13-Aug-2018 15:55
    This message was posted by a user wishing to remain anonymous

    Hi all,

    Does anyone know of a website or webinar that helps explain how to create SEND dataset files? Perhaps any software out there that helps with the creation of these files (they must be huge!)/

    This looks quite complicated.

    Thank you!
    Original Message


  • 7.  RE: SEND Datasets with initial IND

    Posted 14-Aug-2018 09:23
    We use the CRO or a 3rd party vendor to create the data sets.  A list of registered solutions providers can be found here.

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    Kaitlyn Riffel
    Kansas City MO
    United States
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    Original Message


  • 8.  RE: SEND Datasets with initial IND

    Posted 01-Nov-2020 20:44

    Hi,

    I confirm with the previous comments that SEND dataset will be require for your IND submission for studies related to single-dose tox, repeat-dose tox and carcinogenicity.
    Like Kaitlyn mentioned above, we also took the conservative approach in our initial INDs of providing SEND Dataset for both non-GLP and GLP studies. 
    The FDA will most likely required the SEND Dataset as part of your initial IND and this can be the subject of a potential clinical hold if not provided, so if your goal is to provide the SEND data in the 120 days post-submission, I would advice to make agreement with the FDA PM first, as this might be acceptable on a case by case basis.

    Usually, the SEND Dataset are done at the CRO who performed the study, and from what I know, it can take approximately 4 weeks for a non-GLP study, and between 4 to 9 weeks for a GLP study depending on the CRO. 




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    Charlene Revel
    Senior Regulatory Scientist
    Cambridge MA
    United States
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    Original Message


  • 9.  RE: SEND Datasets with initial IND

    This message was posted by a user wishing to remain anonymous
    Posted 06-Nov-2020 09:24
    This message was posted by a user wishing to remain anonymous

    Thanks for the replies. FDA did confirm they will not accept SEND within the 120 window and require it for any draft reports at the time of the initial IND. Resubmission of SEND (-f there are any changes to the dataset submitted with the draft report at the time of the final report submission-would require a resubmission according to the data using the "replace" operating per the conformance guide.  Refusal to file will eventually occur automatically at the gateway without SEND for the required modules once the Technical Rejection Criteria (TRCs) are in place for SEND. Thanks again!
    Original Message


  • 10.  RE: SEND Datasets with initial IND

    This message was posted by a user wishing to remain anonymous
    Posted 09-Nov-2020 15:54
    This message was posted by a user wishing to remain anonymous

    We have had our nonclinical consultant indicate that they have not seen initial INDs placed on a clinical hold if SEND was not included with the initial IND submission during this period when the Technical Rejection Criteria (TRCs) are not yet in place.  We are currently planning an IND submission that will include some nonclinical studies starting after December 17, 2017 for which SEND data may not be available at the planned time of IND submission.  I would be interested to hear if there are any concrete experiences of an IND being put on hold due to a lack of SEND data and if so what Division as I imagine this differ by Division as well.  I have let the team know there is some risk to the current strategy, but they currently feel it is low risk and if the risk is  actually higher I'd like to alert them to that fact. 

    Original Message


  • 11.  RE: SEND Datasets with initial IND

    This message was posted by a user wishing to remain anonymous
    Posted 09-Nov-2020 16:35
    This message was posted by a user wishing to remain anonymous

    Our FDA Tox team leader did clearly state that SEND would be required for all draft or final reports required to support our IND. This is consistent with the webinar from June of this year. If it's a supportive study that would not require SEND, you can place in the appropriate module (with out simplified TS xpt files in the absence of TRCs for now).  It's easy enough to inquire with yore FDA reviewer and I would advise doing so rather than risking a RFT. I hope that helps.
    Original Message


  • 12.  RE: SEND Datasets with initial IND

    Posted 29 days ago

    Hi Charlene,

    Do we need to submit bioanalytical validation documents along with send report in IND? Or just send data package is enough?

    Regards,



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    sapna rathi
    Regulatory specialist
    AHME
    India
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    Original Message


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