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When the "clinical significance has not been established" footnote is required
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Hi there,
I'm a bit unclear as to when the "Clinical significance has not been established" footnote is required. I understand in general that it would be required when non-clinical features are implied to have clinical significance, however, I guess I am unclear on what PAAB considers "non-clinical features". I know it includes MoA and (I think) ingredient-related claims (e.g., "Drug Z contains no added chemicalY"), but beyond that, I am unsure.
For example, would a claim like "More than X patients prescribed worldwide" require the "Clinical significance has not been established" footnote? Would that be considered a "non-clinical feature"?
Any help would be greatly appreciated! Thank you very much!
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Hey @kshulist
The disclaimer is generally requested when any non-clinical features/characteristics extend to/may suggest a clinical benefit. This would include experience claims such as the example provided (# of patients worldwide). The disclaimer is presented to be clear that the number of patients worldwide should not be extrapolated to significance of the efficacy or safety profile of the medication. As a courtesy, the copy “prescribed worldwide” would have to be supported with validated global data which tracked prescriptions to validated new patients.
