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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?