Implications of updated safety information in Product Monograph
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Hello,
The Product Monograph for a drug I work on is being updated. Specifically, there is adverse event information being added from a Dose Regimen study (which doesn't have a placebo arm). This data will be presented separately from the adverse event information from the placebo-controlled studies. My question is: what implications will this have for safety claims in promotional pieces? If we were to make a claim of "demonstrated safety profile", would we necessarily need to include the most common AEs from BOTH the placebo-controlled and Dose Regimen studies?
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Hey @JDilly11
Hard to provide comments without seeing the updated TMA copy. This question is likely better submitted as an opinion so that we can look at the update and the nature of the claims being made in current or proposed future pieces. As a general guiding principle, the assessment is made by looking at the update in combination with the APS copy to ensure it reflects the same context as the TMA. If there is something that would trigger the inclusion, then it will likely have to be added. Whether both data presentations are required will also depend on the APS copy and the finalized TMA copy.
