286 - After putting the NOC/c boxed statement on the front cover, can additional related statements go on the inside of the APS - or does it all have to appear on the front cover?
Jennifer Carroll last edited by
I think you are referring to the base fair balance (correct me if I am mistaken). The base fair balance may appear inside of the booklet. Of course, there are times when a specific claim on the cover triggers the need for a particular element of the fair balance to be presented on the cover (i.e. copy-specific balance). As of July 2013, the PAAB code will require content setting the boundaries of patient selection from the Indication and Clinical Use section of the product monograph to be presented on the first surface containing drug claims. This requirement is already in place for new products, but it will apply to all healthcare product advertising reviewed by PAAB as of July 1st 2013. If this information is already conveyed in the NOC/c box, there is no need to repeat it.