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Confide labeling promos must be included at point of assembly following warning letter.

This article was originally published in The Tan Sheet

Executive Summary

DIRECT ACCESS DIAGNOSTICS CONFIDE POINT-OF-PURCHASE LABELING PROMOTIONS will be included in the HIV home test kit pack-age at the point of assembly under a corrective action plan agreed to by FDA. A recent promotional campaign that involved affixing FedEx envelopes and stickers to the kits at the point of sale drew a March 31 warning letter to the firm after some of the envelopes and stickers were inadvertently attached to competing Home Access HIV test kit boxes by retail pharmacy employees.





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