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Thank you, Jennifer. Is it saying it that in the absence of Canadian guidelines, US guidelines can be used without a letter of endorsement from a Canadian healthcare body?

Hello! Could you please clarify whether US guidelines are considered to be international guidelines in the following statement:

"In the absence of Canadian guidelines we can consider US or North American guidelines. In the absence of those, we can consider international guidelines. When an international guideline is being submitted, we require authoritative support that the International guidelines are endorsed by a recognized Canadian health
professional organization representing this therapeutic area."

This statement sounds like US guidelines do not need Canadian endorsement, whereas international guidelines do. Wondering if you are separating out US/North American guidelines from international guidelines. Could you please specify when specifically the Canadian endorsement is needed for guidelines (assuming there are no Canadian guidelines available)?

Can you please clarify if pooled long-term extension data can be considered, assuming the original pivotal studies are part of the TMA? I've review the guidance on duration of clinical trials and it seems to assume that the LTE is the continuation of a single study. What if there is a pre-planned open-label LTE where patients from the various pivotal trials are fed into one pooled LTE?

We have been provided with before and after images of a real patient who used the product and had an improvement in their skin condition. The images were provided from a medical doctor with the patient's consent and anonymized. We want to include the images as part of an HCP-facing patient profile. What sort of supporting documentation do we need to provide in terms of letters or attestations? Are there other considerations involved with using real patient before and after images?

Is a meta description still needed for each page behind the gate of a patient-facing product website when there is a no index command? Since we don't what the pages to be found on search, then wouldn't the meta description be useless or potentially reveal product info to a general audience? If the meta descriptions are still needed, wouldn't the meta description have to be balanced and referenced? That's a lot for 160 characters. Could you please clarify what's needed from meta descriptions in the case of gated patient content about a product?