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165 - Would a cover/folder carrying the product monograph in its entirety (no edits, verbatim PM) require PAAB review? The cover/folder would have branding colors/ design (no implied claims) and simply state: "Brand X Product Monograph".

FYI post-approval change/preclearance exemption/what requires review/PAAB scope

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Jennifer Carroll last edited by

No it would not.
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