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  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 58 - For an advertisement stating that sample packages for Product X are available from company Y's pharmaceutical sales representatives, would PAAB preclearance review be required?
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58 - For an advertisement stating that sample packages for Product X are available from company Y's pharmaceutical sales representatives, would PAAB preclearance review be required?

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

    If it is simply a sample availability message (with no additional message or embellishment), it would not require PAAB review, however, the sample holder / kit may be subject to the PAAB review depending on the content on the box. Please note that a simple message of product availability (Product X available from Company Y) would meet the current PAAB Code exemption (s1.5)

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