Product Monograph Comparisons
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We understand the guidelines regarding what can and can't be included in a PM comparison of several products. This question is limited to the products included in the comparison. Let's say the table is a comparison of a specific drug class with the same indication and that there are about 10 products on the market. What does PAAB require as support that some products do not need to be included in the table? What are the guidelines to determine what products need to be included in the comparison and what products can be excluded? Or is at the discretion of the manufacturer developing the table?
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We understand the guidelines regarding what can and can't be included in a PM comparison of several products. This question is limited to the products included in the comparison. Let's say the table is a comparison of a specific drug class with the same indication and that there are about 10 products on the market. What does PAAB require as support that some products do not need to be included in the table? What are the guidelines to determine what products need to be included in the comparison and what products can be excluded? Or is at the discretion of the manufacturer developing the table?
Hello @lags
This is a complex question that would be better suited as an opinion submission where details on the therapeutic area, class of products, proposed inclusion and exclusion criteria etc. could be provided. It is not possible to create an exhaustive list that would be clear enough to apply across all therapeutic areas. As a general response, any selection criteria that have eliminated other products from the presentation, should be clearly conveyed along with disclosure to the audience that this is a selective presentation.
