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226 - I have been contracted by CTC Communications to aid in developing an application program on a product for a chronic arthritic condition with a high indication of depression/anxiety in patients. Like most chronic illnesses, the incidence of a mood disorder is high - this has nothing to do with the drugs treating the arthritic condition (i.e. the drugs are not causing or treating the mood disorder). In this program, no claims are made regarding the product (i.e. no claims are made that the drug helps depression/anxiety), it simply offers education and rating scales on depression/anxiety. Does this program need to be PAAB approved? Furthermore, what...
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continued ... elements of the program need to be passed through PAAB? The elements include: *Content in the application *Information handout on the application that the representative may leave with the physician *Paper or e-detail on the application that the representative may use to detail the physician on the application Thank you for your feedback in advance.
Response: This appears to be the same question as 224. Please see answer 224.
