Hello @adelaidebaker As a general principle, the clinical decision to prescribe or switch should be made based on clinical considerations. Patient preference can be a part of a patient profile but should not be positioned as the reason to prescribe or switch. Patient preference can be presented as a consideration, without drawing conclusions about clinical actions. With respect to the specific case presented in the question, the copy in the guidelines and the APS would have to be assessed at the time of submission. We’d caution that “broadly defined” may be problematic and that drawing inference around patient choice such as “difficulty remembering to take pills and therefore might prefer injections” would require statistically significant evidence from a published high quality source.

Hi @support A strictly informational statement about stock such as “Product X 5mg dose now back in stock” could be considered exempt. The inclusion of the indication statement renders it no longer exempt. The inclusion of a product photo MAY render it no longer exempt. This piece should likely be submitted for an exempt opinion to assess if the product photo can be used while meeting exempt criteria.

Hello @msargeant Apologies for not seeing this question sooner. Per 3.1.1, post-hoc analysis are generally not considered acceptable evidence at this time. The circumstance in which post-hoc analyses would be considered acceptable is outlined in the statement that follows that copy which states “Data included in the TMA may be acceptable”. HTH.

Thank you @Jennifer-Carroll!

Thank you @Jennifer-Carroll. This is very helpful!