265 - Please explain "Claims relating to PRO endpoints must appear clearly within the context of the Health Canada approved indication." Does this mean that data from PROs must be in the PM, or just that the PM must address the outcome being assessed (e.g. "Drug X treats condition Y, and the pain from condition Y", for the PRO of pain reduction).

  • That specific provision is simply meant to convey the following: The relevant indicated use must either appear in the PRO claim or in the context leading into it. The overall message should convey that the PRO outcome is secondary to management of the indicated use (rather than a separate product use). For example, the journal ad headline "Product X demonstrated improved QOL versus placebo" should actually read "In the management of MDD, product X demonstrated improved QOL versus placebo". That provision should be interpreted in the context of all other relevant provisions. As an aside, note that acronyms should be defined.