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?

  • 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.