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.
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Frank Faunce
Abbott Laboratories
Abbott Park IL
United States
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Original Message:
Sent: 10-07-2012 10:09
From: Darlene Rosario
Subject: Submission type for pre-IND meeting request
Michael,
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,
Dar
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Darlene Rosario
VP Regulatory Affairs and Quality
Biothera
3388 Mile Collins Dr
Eagan, MN
United States
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Original Message:
Sent: 10-05-2012 15:16
From: Michael Frantz
Subject: Submission type for pre-IND meeting request
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
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Michael Frantz
Senior Specialist, Regulatory Operations
Dyax Corp
Burlington MA
United States
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