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Special FeaturesLast update October 8, 2019

Ask PAAB

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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.

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497

I would appreciation clarification of Section 6.6 of the code related to patient information direct from and consistent with the Product Monograph in combination with gating requirements. If a video is created that walks a patient through how to administer the injection as per part III, does not mention what the product is used for, and that video is posted (with no gating) on the company's website right below the product monograph for that product (as you know companies typically have a page on their company site with all their product monographs posted)......is 1) that video exempt from PAAB review and 2) Can the video be left ungated in this situation (i.e. Does proximity to the monograph pose an issue)? Thank you.

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Jennifer Carroll
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