Anon,
Agree with Michelle's approach - that's one way to do it.
But there are times when a pre-IND meeting is sought and the sponsor may eventually decide not to proceed with an IND at all. Typically small organizations may also lack publishing resources and once you are making submissions to an IND (if you request an IND number), you have to submit in CTD which requires publishing resources. So if you request an IND number, you may need to employ/engage regulatory publishers to make the submission.
If you are indeed from a small organization, I would suggest downloading the Webtrader application from FDA (see link below for instructions) and then you can submit anything you want to the FDA in a non-eCTD format [prior to having an assigned IND number], such as a meeting request:
https://www.fda.gov/media/102736/download------------------------------
Saurabh Kothari MSRA, MSBE, RPh, CCRP, RAC
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Original Message:
Sent: 17-Aug-2019 07:37
From: Michelle McGuinness
Subject: meeting request
Dear Anonymous,
First request the IND number from the FDA via email.
Follow the instructions at this link: https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/requesting-pre-assigned-application-number
In my experience, the FDA processes these email requests and provides the IND number within a week.
Then submit your meeting request and briefing book with the IND number you receive.
Kind regards,
Michelle
------------------------------
Michelle McGuinness
Consultant - Quality Assurance, Regulatory Affairs & Commercial Compliance
Glenmoore PA
United States
Original Message:
Sent: 16-Aug-2019 11:55
From: Anonymous Member
Subject: meeting request
This message was posted by a user wishing to remain anonymous
Hi,
How do you submit a meeting request and the meeting briefing book without an IND number? This is a pre-IND meeting. Should they go to an FDA email ID or a particular division email ID? or do you need to contact the FDA first and ask where to send it?
Thanks