Pre-NOC layout submission

[Supraja]

Hello,

I understand that when copydeck and layout are submitted together, the copydeck will be reviewed for content and the layout will be reviewed for positioning/visuals.

With the goal of developing our 2 core pre-NOC pieces as far as possible while we await NOC, we are considering submitting layout alongside copydeck in the initial PAAB submission.
Could you please advise on whether this would be permissible, and whether this would enable us to receive PAAB feedback on copy and layout 15 days after submission? On the same note, would we be able to submit a layout concept or draft (approved by manufacturer's med-reg dept) for that initial PAAB review along with the copydeck?

Would appreciate your guidance on this, thank you!

[Jennifer Carroll]

Hey @supraja

The review practice for pre-NOC reviews differs only in that the sponsor is limited to two pieces and that the review turn around time is at PAABs discretion based on office workload. It is acceptable to submit the layout and copydeck in the initial submission of all files. Where there are significant changes required, comments on layout will be restricted to the aspects unaffected by the copy changes. Opinion reviews on creative are also an acceptable route to gain guidance early on in the development and would not count towards the 2-piece limit.

[Supraja]

@jennifer-carroll Thank you!