Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
Advise on a symptom tracker app; does this need PAAB review?
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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?
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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?
Happy Friday @iainb
A symptom tracker that relates to a disease and not medication AE’s or medication outcomes, which contains no branding elements, could be considered exempt if there was no mention of treatment. If the tool speaks to treatment (even in an unbranded context) it would be subject to review. PAAB can provide an opinion if the piece is exempt. If you’ll want to proceed to approval if the piece is not considered exempt, please indicate this in the submission letter.