Hi Ken,To confirm, you need to request a pre-IND meeting if you don't have an IND in place. This would allow you to connect with the FDA regarding the studies needed for a NDA using a 505(b)(2) pathway.
As for submitting the meeting request as eCTD via Gateway, it might be best for you to contact the division's project manager and ask if they would accept the submission by portal. I read on previous posts that FDA could accept PIND meeting requests through CDER NextGen Portal - though I cannot confirm this nor have I ever used this portal. You can no longer submit in paper.
My suggestion would be to submit your PIND meeting request and subsequent briefing package by eCTD. It would be easier to maintain and track in the future.
Hope this helps but let me know if you have further questions.
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