Pre-NOC Submissions

GMC

With the new Pre-NOC Guidance document, is there a limit to the number of submissions (rounds) we can make for an APS being reviewed during the pre-NOC period?

Jennifer Carroll

Hey @gmc
Within a pre-NOC submission, there is no limit to the number of rounds of resubmission you can make during the review prior to acceptance.

There are, however, a few considerations when it comes to resubmissions and number of rounds:

As with any type of APS submission, a supplemental fee will be invoiced on the third resubmission. Additionally, a supplemental fee will be applied every third resubmission thereafter until approval.
If a major change is made to the APS or TMA mid-review, a new file with a new fee may be requested. Please see Appendix A of our Administrative Guideline for the Review of Pre-NOC APS for more information on when a new submission may be requested.
Standard expiry of files at 6 months of inactivity or 12 months since opening still apply.

With these considerations in mind, we review most APSs in a single submission despite the number of rounds required.

GMC

Jennifer, the Guidance document is not clear on the turnaround time for submissions immediately post-NOC with the final Product Monograph. Would any ARO options be available? Would it be a standard 10-day turnaround? Would it be shorter?

Jennifer Carroll

Hello @gmc

Please see Appendix A for turn around times. Turn around post approval is impacted by the final approved PM and if it is different from the PM in the previous round of review.

Whether ARO is available for additional pieces would depend on the ARO requirements (i.e. length, new content, etc.).