Combining two PAAB-approved jobs into one
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My client has a PAAB approved folder/pocket that has efficacy information on the front and high-level fair balance on the back. The folder was submitted to PAAB along with tabbed inserts for dosing and administration information and patient profiles. They have all been approved under the same PAAB efile number. Later on, an MOA card was created and approved under a separate efile number. Are we violating any policies by inserting the MOA card into the folder?
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My client has a PAAB approved folder/pocket that has efficacy information on the front and high-level fair balance on the back. The folder was submitted to PAAB along with tabbed inserts for dosing and administration information and patient profiles. They have all been approved under the same PAAB efile number. Later on, an MOA card was created and approved under a separate efile number. Are we violating any policies by inserting the MOA card into the folder?
Based on the question, we understand that the folder and tabbed inserts were reviewed as a single file, in a fixed order. If the MOA card was submitted without explicitly indicating to the reviewer that the card was to be used with the folder and other tabbed inserts, then it should not be inserted into the folder. PAAB has not reviewed the MOA card within the context of the folder/other tabbed inserts. Content/positioning of the inserts may affect the relationship between the content of the inserts that may be inconsistent with the PAAB code. We suggest submitting the folder/inserts efile for an update with the MOA card and clearly indicate where it will be placed with the folder.
If this was a branded folder containing several, discrete, approved, branded APS that can stand on their own, adding another discrete approved branded APS would not require re-review.
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Based on the question, we understand that the folder and tabbed inserts were reviewed as a single file, in a fixed order. If the MOA card was submitted without explicitly indicating to the reviewer that the card was to be used with the folder and other tabbed inserts, then it should not be inserted into the folder. PAAB has not reviewed the MOA card within the context of the folder/other tabbed inserts. Content/positioning of the inserts may affect the relationship between the content of the inserts that may be inconsistent with the PAAB code. We suggest submitting the folder/inserts efile for an update with the MOA card and clearly indicate where it will be placed with the folder.
If this was a branded folder containing several, discrete, approved, branded APS that can stand on their own, adding another discrete approved branded APS would not require re-review.
@jennifer-carroll Thanks very much for your feedback.
