789

To a currently marketed product, and instead of a "now available" message, the message is " has been granted market authorization for additional indications"? (Again, with or without a link to the updated PM Hi There. I've seen several questions that have circled this issue, but none that have addressed it head on: Is an electronic message to physicians that consists entirely of the message that a product has been granted market authorization (without mentioning the indication or therapeutic category), plus the sender's contact details, exempt from pre-clearance? Please assume the message will be sent by sales reps or commercial head office staff. What if this same message also includes a direct link to the product's unedited product monograph? What if the message relates to a label-extension)

A message of "now granted market authorization" is a claim that requires support and substantiation (authorized for what). This is different than a market access claim of "now available". The inclusion of the indication would automatically prompt at least lowest level fair balance. The same would apply to a label-extension. These messages would not be exempt. Please see Q&A 740.