326 - Can we create a comparative timeline of 2 products (1 ours and 1 a competitor) from the same therapeutic category and who have some of the same indications? The timelines would only show indications, which ones each product has and when they were received. Thank you.
-
Comparisons of product properties are permissible as per Code section 5.10.2iii. The comparison should be complete, with no information relevant to the comparison omitted (e.g. the indications must each be complete). The comparison must not appear in the context of messaging implying clinical significance. A disclaimer is required as outlined in the above noted Code section. With regards to the dates, keep in mind that there should be no direct or indirect reference to the approval process ad per c.01.007 of the Food and Drugs regulations.