We have developed a symptom tracking app for a rare disease on behalf of a pharmaceutical client. The app is not overtly branded but does state that it is "Developed and funded by..." the pharmaceutical company, and the company is referenced in the Terms and Conditions and Privacy statement. The app is for patients to track their symptoms and help them to explain any changes since their last HCP appointment. All data is stored on the patients device and not shared with any online repository, though the option to be able to share information with their HCP via email will feature in a coming update. This app has already been released for download across 19 countries in the EU and the UK. Does this app need to be PAAB reviewed? And if so, what label or badge would need to be shown on the Canadian versions of the app?
I
IainB
@IainB
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB
correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system.
Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly
prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.