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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 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?
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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?

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

    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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