321 - A patient information brochure will NOT mention the product but will bear the name of the manufacturer. It will be distributed by the rep to the requesting health care professionals. Will this still need PAAB review?
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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 )
