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535 - The manufacturers of a drug would like to provide patients (via HCPs) with a wallet card that alerts the patient to show the card to healthcare professionals to remind them to check for potential drug interactions. This focused bit of information is consistent with Part III. Does this require PAAB review?
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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Patient information that will be distributed by or recommended by a health care professional falls under the PAAB scope of review. The question then becomes whether it is exempt from review. As in Ask PAAB #321, a patient piece generated by the manufacturer or its agent requires PAAB review unless both of the following conditions are met: there is no discussion of drug therapy (by product, class, or category) there is no discussion of drug issues (e.g. adherence to medication, potential implications of product ingredients…etc.) The card discusses the issue of interactions in the context of the drug therapy and therefore requires PAAB review.
