Video-in-print and ISI req'ments
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For a video-in-print brochure/box for HCPs that includes buttons to play MOA and administration videos, does the ISI need to appear within each video (i.e. same medium the claims are in) or can it appear in print (high level) on the brochure/box alone
@tammy-0
We understand the ISI as a reference to the indication and fair balance/safety information requirements per code section 2.1, 2.10 and 3.5. If the MOA/administration videos will only be used with the print brochure/box, the fair balance requirements may be included on the box alone and should be appropriate for any claims on the brochure as well as the videos. Should the videos be intended to be used separately as well as with the print brochure/box, they would require separate review and the indication and fair balance/safety information should be on the actual videos themselves.
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@tammy-0
We understand the ISI as a reference to the indication and fair balance/safety information requirements per code section 2.1, 2.10 and 3.5. If the MOA/administration videos will only be used with the print brochure/box, the fair balance requirements may be included on the box alone and should be appropriate for any claims on the brochure as well as the videos. Should the videos be intended to be used separately as well as with the print brochure/box, they would require separate review and the indication and fair balance/safety information should be on the actual videos themselves.
@jennifer-carroll Thank you for the clarification.
