Initial Full Approval after PAR Experience
I have now had a couple experiences with the new process of submitting revised forms for prior approval after a post-approval review ("PAR") is complete. In addition to the issues raised here previously about this, one question that has come up is the status of forms that are not revised in the PAR.
For example, an original submission had 10 true policy forms and each had variable material. The hypothetical PAR is complete and there were no violations of law, regulation or circular letter found, but the examiner requested a variety of minor changes in the review - but only on 3 of those forms and on 1 Statement of Variability. Under the new procedure, a closing letter would be issued on the post-approval and a request made for a new prior approval submission.
In my experience the request for a full prior approval submission would be for the 3 forms and 1 SOV as those were the only forms from the original submission that were revised during the review process. But what then is the status of the other forms in the original submission? The SOVs for the 3 true policy forms would have to be re-submitted because the 3 forms will need new form numbers so the original SOVs won't line up any longer. The other forms were approved on a CL6 basis and apparently reviewed, but no comments were made on them and no revisions requested in the PAR. The revised forms that have to be re-submitted will be returned with a full "Approved" stamp. But what of those others? Shouldn't all the forms that receive a full review by the examiners, even if it is in the context of a PAR, receive that "Approved" stamp? Under this new process, a single original CL6 submission package could ultimately have several different dispositions after a PAR and resubmission on a prior approval basis. This adds yet another level of complexity to already difficult product filing decisions.
