220 - A couple colleagues have recently indicated that Annotated Product Monographs are beginning to be subjected to more stringent restrictions by the PAAB. Both indicated that the reason was that by calling out certain elements of the product monograph that it was creating "undue emphasis" on product attributes. This raises two questions: 1. How does this differ from a typical sales aid whereby charts and compelling data points are given emphasis and fairly balanced with appropriate safety information, etc. AND 2. Doesn't the fact that an annotated Product Monograph contains all pertinent balancing information in one easily accessible tool not by default ensure that appropriate caution was exercised in highlighting data? Furthermore, is this a recent development? I can recall within the last 2 years working on several of these tools with no such objections from the PAAB. Thanks in advance for your reply!
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PAAB has created a guideline document for annotated product monographs. It summarizes how PAAB has already been reviewing annotated product monographs. We have not added "increasingly stringent restrictions". You can still use callouts in the margins of the document (I assume this is what you are referring to ). Call me and we can talk about it.
