523 - Hello, I would like clarification on how efficacy data and mechanism of action data can be presented together in a promotional piece. My understanding is the MOA is considered non-clinical and therefore must be physically separate from efficacy or clinical claims. Is this assumption correct? I am not sure why this would be. Can you please explain why I cannot mention how a product works and how well it works together in a page? Thank you,

  • Correct. Clinical and non-clinical messages must appear as separate and distinct presentations so as not to suggest associations between both messages which have not been substantiated. This does not necessarily mean that the information must be presented on separate pages. Your reviewer would be able to explain how to present these messages on the same page while still keeping them separate and distinct. Note though that this may require significant revisions to the page layout which might ultimately compel you to simply present the information on different pages.