Exemption for unbranded tool of single product within category
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If there is only one product available on the market within a particular category, would the tool be considered exempt from preclearance if the tool talks about the MOA of the category?
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Hello @natbourre
An unbranded APS can be considered exempt if it discusses only disease information without any mention of or allusion to drugs/medications/pharmacotherapy. Because the tool would be alluding to medication/pharmacotherapy via discussion of MoA, the APS would not be considered exempt.
