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    640 - Code s6.6(i) states that materials independently prepared with industry involvement limited to sponsorship/distribution are exempt from review. Can you confirm if 3rd party influencer/blogger social media posts are therefore exempt from review, if industry involvement is limited to paid sponsorship?

    FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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    • Jennifer Carroll
      Jennifer Carroll last edited by

      No. A blog is NOT independently prepared if the manufacturer (or it’s agent) is sponsoring the influencer/blogger. A pharma sponsored blog about drug therapy is therefore likely subject to advertising regulations. Consequently, if it is targeted to HCPs it would fall within the scope of PAAB preclearance. If it is open to the general public, DTC regulations would apply (PAAB offers an advisory opinion for such pieces).

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