Hi, I am working in a therapeutic area that currently has no Canadian guidelines. A relevant standard-setting organization, on their website, acknowledges that there are no Canadian guidelines and directs HCPs to the US guidelines. Could this constitute adequate endorsement? Thanks!
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Posts
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What constitutes "endorsement"? -
PAAB changes to application/requirements for piecesHello,
I recently submitted a piece with an approved claim of "X years in Canada across indications," and found out that PAAB is now requesting that the year of each indication's NOC be added to the claim. Would it be possible for PAAB to provide an explanation of why this change happened, why the code was previously considered in accordance with the code, and also would it be possible for PAAB to provide notices when general changes on how PAAB decides to interpret and apply the code are made? It is difficult for us to explain to clients on why PAAB suddenly feels that the content violates the code, as no explanation is provided on the change.A similar example is that directing HCPs to pre-gate websites now requiring a disclaimer, no notice was given to agencies prior to receiving response letters requiring this disclaimer. These changes in how the code is interpreted and applied creates a lack transparency.