NOCc and Guidance on Duration of Clinical Trials
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Hello Jennifer. What are the implications of an NOCc on the use of extension studies in advertising? This refers to the "Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising."
Hello @lags
In Guidance on Advertising for Drugs with Notice of Compliance with Conditions (Noc/c), point 3 states: “For NOC/c product advertising, studies and/or data which are not presented in the Terms of Market Authorization will not be accepted”. The referenced extension studies guidance would not supersede this restriction.
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Hello @lags
In Guidance on Advertising for Drugs with Notice of Compliance with Conditions (Noc/c), point 3 states: “For NOC/c product advertising, studies and/or data which are not presented in the Terms of Market Authorization will not be accepted”. The referenced extension studies guidance would not supersede this restriction.
@jennifer-carroll Thank you.
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Hello @lags
In Guidance on Advertising for Drugs with Notice of Compliance with Conditions (Noc/c), point 3 states: “For NOC/c product advertising, studies and/or data which are not presented in the Terms of Market Authorization will not be accepted”. The referenced extension studies guidance would not supersede this restriction.
@jennifer-carroll Hello! We're wondering how this ruling applies when the extension study results for a NOC/c product are described in the PM, but the data are omitted from the PM. This is commonly presented in the PM as "the results of the extension study were consistent with those of the earlier analysis".
The quote from the Guidance states "studies and/or data which are not presented...". In these cases, the study is presented in the TMA, but the the data are not. The way the study is presented also implies that the results were favorable (since they aligned with the earlier analysis). Can we include the study data in this case, and if so, would it be able to be presented in a promotional manner?
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@jennifer-carroll Hello! We're wondering how this ruling applies when the extension study results for a NOC/c product are described in the PM, but the data are omitted from the PM. This is commonly presented in the PM as "the results of the extension study were consistent with those of the earlier analysis".
The quote from the Guidance states "studies and/or data which are not presented...". In these cases, the study is presented in the TMA, but the the data are not. The way the study is presented also implies that the results were favorable (since they aligned with the earlier analysis). Can we include the study data in this case, and if so, would it be able to be presented in a promotional manner?
Hello @dmauri
The guidance does not apply to NOC/c products and therefore has no bearing on data reviews for NOC/c products. The standard NOC/c approach remains the same (see Guidance on Advertising for Drugs with Notice of Compliance with Conditions (NOC/c)). If the data or study are presented within the TMA, we will allow it in the same context within promotional pieces. When assessing copy similar to “the results of the extension study were consistent with those of the earlier analysis”, clarity on which endpoints and the same tonality and direction will be required. Additional comments may arise pending review of the language used throughout the TMA.
