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6 - Do patient education tools that are distributed by physicians and endorsed and approved by a national medical society or organization of specialists need be approved by PAAB?
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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I am not sure if the question is worded in a manner that was intended. I note "distributed by physicians" and "approved by a national medical society". If no pharma company is involved in the project in any way, the answer is "no". If a pharma company is involved in the sponsorship for production or distribution, it may seen as "advertising" subject to PAAB review if it appears to be promoting the sale of a product.
