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  4. 624 - For an HCP targeted APS, are references required in the final layout of the piece after PAAB approval (i.e., a reference list at the end of the piece and superscripts throughout)? Or do references not need to be included in the layout once PAAB has approved the copy doc? Thanks!
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624 - For an HCP targeted APS, are references required in the final layout of the piece after PAAB approval (i.e., a reference list at the end of the piece and superscripts throughout)? Or do references not need to be included in the layout once PAAB has approved the copy doc? Thanks!

Scheduled Pinned Locked Moved Submission Requirements/process & Timelines/eFiles
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    For HCP targeted advertising, references are required in the final layout of the piece. Yes, as you said, this entails a reference list at the end of the piece and the corresponding superscripts throughout the piece. An alternative is to use the superscripts throughout the piece but include the corresponding reference list in a web location corresponding to a URL presented on the piece. See the PAAB code sections 4.4.3 to 4.4.7.

    This is required for adherence to PAAB code section 3.3 (i.e. an HCP would need to know which reference to request from the manufacturer if he/she wanted additional info or wanted to test the evidentiary basis for a claim).

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