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@jennifer-carroll Thank you for your response. As a follow up question, in the context of an RWE publication, would the use of descriptive statistics to evaluate clinical outcomes preclude the use of the publication in a tool? Assuming that the analysis and endpoints were prespecified.

Can trials that use descriptive statistics for their statistical methods be considered in a promotional setting (unbranded or branded)? If trials that use descriptive statistics can be used in APS, what are the considerations for use i.e. disclosures, limited to only one setting?

@jennifer-carroll Thank you for your response! As a follow up question, can you clarify what defines"clinically relevant"?

Assuming that a trial met the criteria of the RWE guidance, would a pharmacogenetic study evaluating a specific population be acceptable if the approved indication of the product was non-specific i.e. general population vs. select demographic? As a secondary point, given that it's a pharmacogenetic study and not an efficacy driven study, would there be any limitations to including data in APS if the results are only pharmacokinetic in nature?

Can we change the eFile that links out of a QR code post approval (assuming no changes to layout or copy to the original APS)? For example, once an HCP branded Journal Ad with a QR code is approved for use, can we update the redirect from the QR code to another branded HCP eFile? If the QR code on the Journal Ad originally redirected to a digitally hosted APS (and was approved), but then once a mobile HCP branded website is launched, can we simply change the redirect? Or would we need to resubmit the Journal Ad as an update and indicate that the eFile has been changed for the QR code?