@jennifer-carroll Thank you so much! This should help us learn 🙂

Hey @palanski

Great question. PAAB’s strategic plan for 2023-2025 includes a focus on increasing the extent to which HCPs value health product advertising and industry-generated patient information. This is the primary motivation for the shift outlined in the disease burden document. This shift is one element of a multi-pronged approach towards that aim. The standards outlined in the document were generated in consideration of our global benchmarking and stakeholder consultation activities.

While health product manufacturers’ have expressed a long-standing desire to provide more detailed presentations of disease states, it took some time to establish a set of standards that effectively aligned that desire with the interests of patients and HCPs. The objective of PAAB is to ensure that disease information (including burden of disease) does not suggest use and efficacy for outcomes which the brand has not been demonstrated to address. This objective remains however PAAB has looked to explore ways that we can meet this objective while allowing more latitude on disease presentations.

In short, the document seeks to outline principles that will mitigate the risk that the disease burdens be interpreted as outcomes that the drug can improve. The document also reiterates the requirement that the disease information and descriptions of disease burden must pertain to the promoted product’s indication.

Our hope is that manufactures will view the guidance document as a collaborative means to providing greater flexibility in relation to disease information presentations in HCP advertising, disease information presentations in patient information, and disease burdens conveyed in creative imagery.

@Manufacturer @Agency

There's still time to sign up and join over 150 people registered for the interactive Q&A session on the Accelerated Review Options (ARO) pathway and the new submission guidance documents.

Registration link can be found in the post above. Hope to see you there.

Thanks for identifying that @palanski !

We've adjusted the privileges so that you should now have access.

@Jennifer-Carroll I've solicited feedback from ANTIBODY's Creative Director, Melisa Barrilli, who had the following thoughts to offer on the bilingual logo:

Although we rarely use bilingual logos, they do come in handy. Glad a version was created! The bilingual logo seems to have optimized the space and flows well. Legibility seems excellent for the PAAB/CCPP words. It will be interesting to see how all versions look when applied at their minimum recommended size—there's considerable size variation with the smaller type, so "Reviewed by" may become illegible if used too small.

Hope this is useful!