New pediatric indication claims
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We are creating an HCP-directed marketing tool with the primary purpose of announcing a new pediatric indication for an existing product. This new indication is currently under review by Health Canada and the APS we are developing will be submitted to PAAB for review following NoC.
We would like clarification on the following:
If the Product Monograph lists this pediatric use under the "Indications" section, but the wording in that section is similar to “Drug X is now authorized for use in pediatric patients…” (rather than the typical wording of “Drug X is indicated for use in pediatric patients…”), would PAAB consider it acceptable for us to refer to this as a "new indication" in our HCP marketing tool? If not, would it be acceptable to refer to this as a "new authorized use"?Thank you in advance for your guidance.
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Hey @mimi77
While we don’t provide reviews of the Forum, in general terms the claim should reflect the nature of the update. From our understanding of the description, this would be authorization in a new population (pediatrics) and not a net new indication. As such, claims should reflect “Now authorized for use in pediatric patients for x” or something similar.
