397 - If you are creating a Pt Booklet based on Part III of the Product Monograph, can you also include a patient-friendly description of the primary efficacy outcome? If so, how about primary and secondary efficacy outcomes?

  • Product content is limited to that which appears in part III of the PM. Unless the study endpoints are discussed in part III (which is unlikely), you cannot discuss the study outcomes in the patient piece (even in patient friendly language). PAAB s6.