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We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.

Most Recent Questions and Answers

What is the status of advertising of Schedule II drugs (non-Pr but behind the counter) to the general public? Beyond name, price, quantity?

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How long does PAAB approval on DTC last? 1 year or 2 years?

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I am wondering how or if section 103.2 of the Natural Health Product Regulations factors in to the review of NHPs as it appears to exempt some NHPs from part of section 3(1) of the Food and Drug Act.

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If exacerbation rates are provided in a publication with other details with which NNTs can be calculated, would PAAB allow us to promote the NNTs?

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The PAAB does not allow the use of post-hoc study analyses to support claims. Are there any exceptions to this? For example if the post-hoc analysis was done for safety reasons at the request of the FDA, would that publication be permitted to support claims?

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Hi! Do corporate branded educational tools (no claims or messaging) need to be reviewed at paab? For example : knee bone joints? Or skeleton etc Thanks!!

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Dear PAAB - would a branded APS comprised of only a provincial listing (with clinical criteria/notes), require high-level balance or low-level balance? Note this assumes that all listing criteria is on-label.

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Dear PAAB Can the branding of disease specific information for medical professionals resemble the branding of a product not yet launched? (i.e. Does PAAB place any restrictions on the branding of disease specific information and product APS?)

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We were granted a new indication based on a pivotal study. However, some datapoints in the published study, in a peer-review journal, are not found in the TMA. We would like to know if it is "off label" for our reps to speak to those data points since it is extra data points in our studied population for which we have an indication? Can they use the reprint and speak to those results?

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Is Pharma allowed to sponsor an independently-developed, physician-managed, online discussion forum? Pharma would have no involvement other than to provide funding for its development. What if the discussion forum is managed by Pharma's communication agency?

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Deputy Commissioner  

Patrick Massad
Deputy Commissioner

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