627 - We would like to make non-clinical comparisons between products that are specifically indicated for different subtypes of a disease state (eg. phenotypes of COPD). Would this be acceptable, given the common umbrella disease state?



  • No. The specific indication for each product must be the same. If the products are indicated in different subtypes, they are not considered to have the same indication and therefore should not be compared. See code section 5.1 and 5.2


Log in to reply