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  4. 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?
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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?

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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    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

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