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  3. Terms of Market Authorization
  4. 202 - We would like to reference other clinical studies from independent researchers relating to our product. Purpose is to highlight other research results & findings on different groups of patients. Research has been submitted with the PLA to support other claims used on the packaging but this research claims additional benefits. Am I able to use this research to state the results from these studies without it being in conflict of the claims made on the packaging/PLA? Please advise.
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202 - We would like to reference other clinical studies from independent researchers relating to our product. Purpose is to highlight other research results & findings on different groups of patients. Research has been submitted with the PLA to support other claims used on the packaging but this research claims additional benefits. Am I able to use this research to state the results from these studies without it being in conflict of the claims made on the packaging/PLA? Please advise.

Scheduled Pinned Locked Moved Terms of Market Authorization
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    PAAB Code Section 3.2 allows for use of published, peer-reviewed Randomized Controlled Trials, that are not in the Product Monograph, to support claims in advertising if the claims are consistent with those in the Product Monograph or labeling.

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