451 - Dear PAAB. I understand pharmacokinetics is considered "non-clinical" information. Is "indication" and "dosing" considered non-clinical information? It would appear to me the condition in which a drug is studied and hence approved and also the dose at which safety and efficacy is determined is extremely clinically relevant and would be considered "clinical information". Thank you for your consideration.
Jennifer Carroll last edited by Jennifer Carroll
A product’s Health Canada approved indication and dosing is clinically relevant. Please note the following common advertising submission pitfalls relating to this topic (not an exhaustive list):Indication and/or dosing comparisons across TMAs are not deemed to be clinically significant. Refer to PAAB code s5.10.2. Although an individual product’s indication and dosing info is clinically relevant*, the significance of the incremental difference in indication/dosing between multiple products is generally unknown. Claims relating to efficacy and/or safety (e.g. duration of effect) must be based on evidence rather than being inferred from characteristics such as dosing frequency. For example, a TMA recommendation for “once daily dosing” does not necessarily equate to “24 hour efficacy”.
*Wording edited to more consistently apply use the of term relevant and significant