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619 - We’re working on a new product launch and our client is looking to do a PAAB-exempt pull up banner (just product logo and legal text), however, this product has received an NOC/c approval. Are we required to put the NOC/c box on the banner, which disclaimer sea the indication statement?
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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Inclusion of the NOC/c box would disqualify the ad from being exempt. Exempt messaging restricted to product name and legal text, would not prompt the requirements for placement of the indication and NOC/c. As a caution, note that if the product logo suggests therapeutic use, this would prompt the requirements for the NOC/c box on the banner and would no longer be exempt from review. PAAB can provide an opinion (see the fee schedule on our website).
