Hello Sapna,
After my first reply, I'm not sure I understand what your question is below.
In the interests of avoiding misunderstanding, my suggestion is for you to review:
https://cdernextgenportal.fda.gov/CDER_FAQ_Page#:~:text=FDA%20CDER%20NextGen%20Portal%20is,report%20information%20to%20the%20FDA.
There is also a provided email address that you can contact for a direct answer to your query.
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Fenton Fong
Vancouver BC
Canada
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Original Message:
Sent: 12-Dec-2023 04:17
From: sapna rathi
Subject: Pre-IND meeting request Guidance
Dear Sir,
Thank you for reply.
From nexgen, can we submit through: FDA alternate submission option?
Regards,
Sapna.
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sapna rathi
Regulatory specialist
AHME
India
Original Message:
Sent: 11-Dec-2023 13:10
From: Fenton Fong
Subject: Pre-IND meeting request Guidance
Hi Sapna,
The ESG portal is the general route for all meeting request submissions. If your chemical compound subject matter is specific to CDER scope, then specifically you can use Nextgen.
You won't be submitting your briefing package until after your meeting request has been granted, at which time you will have been assigned an application number.
Hope this helps,
-Fenton
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Fenton Fong
Vancouver BC
Canada
Original Message:
Sent: 11-Dec-2023 10:45
From: sapna rathi
Subject: Pre-IND meeting request Guidance
Dear All,
For Pre-IND meeting request and brief package , how we can submit to FDA via ESG portal or via nexgen ?
Via ESG portal, pre-assigned number required?
Regards,
Sapna
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sapna rathi
Regulatory specialist
AHME
India
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