Disease information in Risk Management Materials
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Would it be possible to include basic disease information (ie what is x condition? how does it work? What are symptoms? etc) in patient-directed risk management materials? We may need to include it based on requirements from our global company's risk management program. We would anyways be submitting the piece for PAAB review/exemption however it would be good to know in advance.
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Hello @xian50
Per our guidance on risk management tools, RMTs are intended to convey important identified risks, important potential risks and missing information about a manufacturer’s products. Should there be a need to convey what the product does about the condition (based on part III of the TMA) and/or information about the disease, the piece should be submitted as patient information. It would be reviewed per section 6 of the PAAB Code. That review entails assessment of both the content and its sources.
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@jennifer-carroll Thank you for your response. Am I correct in understanding that disease information would then likely be removed if it does not align to the part 3 of the TMA and should instead be submitted as patient information?
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Hey @xian50
The type of information within the piece would be dependent on the type of review you are looking for. An RMT should convey important risk information about the manufacturers product. If the proposed “disease information” does not appear to serve the intent of an RMT, it may be questioned. This would be assessed during the review.
Patient information can contain disease information as well as risk information. Disease information which does not align with part III of the TMA would not be acceptable in the context of a branded patient information piece.
