327 - Hi There, Our client has just received NOC to a new product. They do not have a large Sales Force and therefore is not looking to develop comprehensive materials. They would like to take their approved Product Monograph and highlight key messages within it - not changing any copy/content - but just simple draw attention to specific sections, such as patient groups, efficacy and adverse events. We would submit the highlighted PM through PAAB for approval - but before we go into development I just wanted to confirm this would be something PAAB would allow.
Jennifer Carroll last edited by
Please refer to the Guidance document about promotional monographs on our website:
PAAB would not accept placing highlighting over some sections of the monograph content. Modifications should be presented in such a way as to be clearly distinguished from the PM itself. Per the aforementioned document, you could employ callouts in the margin of the document to meet your desired objective.