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  • 1.  Submission type for pre-IND meeting request

    Posted 05-Oct-2012 15:17
    For those of you sending a pre-IND meeting request in an eCTD, do you use Other as the submission type for 0000?

    Thank you,
    Michael Frantz

    Michael Frantz
    Senior Specialist, Regulatory Operations
    Dyax Corp
    Burlington MA
    United States

  • 2.  RE:Submission type for pre-IND meeting request

    Posted 07-Oct-2012 10:09

    By definition, a pre-IND meeting has no tracking to an IND yet and therefore is really general correspondence and not tracked by serial number; the original IND will be Serial 0000. I am unclear how a pre-IND meeting request follows e-CTD.  I strongly encourage you to review the guidance from FDA on requesting Pre-IND meetings and the information needed to request the meeting and the pre-meeting package.

    All the best,


    Darlene Rosario
    VP Regulatory Affairs and Quality
    3388 Mile Collins Dr
    Eagan, MN

    United States

  • 3.  RE:Submission type for pre-IND meeting request

    Posted 08-Oct-2012 10:40
    Dear Michael,

    If you are referring to the eCTD metadata "submission-type," then you should use "presubmission."  And , yes, you can use "0000" as the sequence number, but you will have to make sure to keep a list of the different sequence numbers that are submitted with their associated serial numbers, that have to start at 0000 with the initial IND filing, to ensure you submit your serial numbers in order.

    Frank Faunce
    Abbott Laboratories
    Abbott Park IL
    United States

  • 4.  RE:Submission type for pre-IND meeting request

    Posted 08-Oct-2012 13:00
    Hi Michael,

    The division would assign a pre-IND number to your meeting request and a PIND file is opened. This number helps you for tracking/filing purposes. PIND number is converted to IND number after IND submission (number carries over).


    [Priyanka] [Kothari] [MS, RAC]
    [Fremont] [CA]
    [United States]