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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 682 - If we create a survey asking about the impact of using intravenous vs. subcutaneous drugs on clinic/hospital resources (personnel, time, money) - and we don't mention the therapeutic area, disease state or a specific drug (neither brand nor non-proprietary name will be mentioned), would this survey be exempt from PAAB pre-clearance?
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The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

682 - If we create a survey asking about the impact of using intravenous vs. subcutaneous drugs on clinic/hospital resources (personnel, time, money) - and we don't mention the therapeutic area, disease state or a specific drug (neither brand nor non-proprietary name will be mentioned), would this survey be exempt from PAAB pre-clearance?

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    Creation and administration of legitimate market research as described in your question, would be outside of the scope of the PAAB code. However, if the intent is to include the survey results in advertising then the survey methodology and results would fall under the scope of the PAAB code. Use of surveys in advertising should be restricted to non-clinical features of a product. As clinic/hospital resources (personnel, time, money) would be considered pharmacoeconomic claims and therefore fall under clinical claims, a survey would not be considered an acceptable source to support these types of claims. We suggest submitting the survey questions to PAAB for review prior to conducting the survey if the intent is to use the results in advertising. For more direction on the creation and use of surveys, we suggest reviewing Ask PAAB questions 590 and 551. (As a courtesy, search “survey”)

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