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    Inquiry on observational study material

    PAAB Q&A
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    • N
      Nimisha last edited by

      We are looking into developing a one pager that contains information on a observational study that is being conducted, and it will be provided to patients that have been prescribed the product by an HCP. This piece will not be promotional in content and is mainly intended to provide the patient with information on the type of study, its purpose and what the patient's involvement in the study, should they choose to participate, will look like. Would a material like this be subject to PAAB preclearance?

      Jennifer Carroll 1 Reply Last reply Reply Quote 0
      • Jennifer Carroll
        Jennifer Carroll @Nimisha last edited by

        Hey @nimisha

        The Distinction Between Advertising and Other Activities speaks to criteria for clinical trial recruitment and when it can be considered to be exempt from advertising regulations. Note that bullet 4 reads “in the case of patient recruitment, no reference is made to the drug manufacturer's name, or to the name of the drug under investigation”. Therefore, it is not possible to meet the requirements in the context of a branded piece.

        N 1 Reply Last reply Reply Quote 0
        • N
          Nimisha @Jennifer Carroll last edited by

          @jennifer-carroll Hi Jennifer, thank you for your response. If the material meets the criteria in the Distinction Document, can you confirm that the HCP prescriber can provide the one pager to patients that have already been prescribed the drug? Would it exempt from PAAB pre-clearance if this is the case?

          Jennifer Carroll 1 Reply Last reply Reply Quote 0
          • Jennifer Carroll
            Jennifer Carroll @Nimisha last edited by

            Hey @nimisha

            Unfortunately, we cannot provide this confirmation as it does not appear that the project will meet the criteria outlined in the Distinction Document (it will inherently be branded). We suggest submitting for an opinion to receive more specific feedback in this specific case.

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