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453 - We are creating a branded device for pharmacist’s physicians to use with patients. The easel is highly visual but does show some disease statistics and mentions classes of drugs/and social protocols, with specific brands of medication. Because this piece is never given to the patient, it comes under the same content rules as tools the patient would take home. Please let me know if you want the device.
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I am not certain, but I believe you are asking whether the piece is exempt from preclearance. If it is created by the drug manufacturer or an agent acting on their behalf, it would appear to require PAAB review from the limited information provided. This type of assessment is best done through our written opinion service (refer to the fee schedule on our website) as we’d be able to base the ruling on the actual content and more details about how it came to be.
