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We just run ISI sequentially through the piece and let regulatory specify if they want certain chunks on certain pages.
Ugh letting the ISI dictate story flow sounds awful
If the brand has ISI guidelines/standards from the past or previous ISI feedback, CW should be aware and able to suggest where they think it should go (with MLR having final say).
Client/MLR. the writer can certainly take a crack at what should go where but it really depends on the brand.
Usually sprinkle one paragraph per spead, no ISI needed on safety pages
I’m not in pharma anymore but it was a client/legal decision. Copy doesn’t even write it.
Depends on the brand. Some you can flow through sequentially. Others the brand will have a preference on what goes with which content.
^^ we also have MLR content managers who help with this
Typically driven by MLR but agency often welcome to weigh in and offer suggestions.
Don’t waste your CW time and energy. Client MRL
Team should tell you what to use. Save your sanity
Was actually working on this today. Typically one section per spread, minus safety content pages. Though our PRC team has been telling us what they want on certain pages, ie, Efficacy should have the Adverse Events section of the ISI. Depends on the brand and LMR/PRC team.
If you have a medical writer they should be able to direct how it should be split up. But otherwise the reg is that it is not minimized on the page/screen. One paragraph per page is a good place to start, but if you have many claims, or very large prominent claims, on a page you may need to add more to that page or make the ISI font size bigger.
Client, not generally, unless they want to "take a chance" for aesthetic reasons. Regulatory, yes. CW, sure, but should be basing judgment on precedent. Editorial guidance, same deal. (Weird that medical editorial was left out of the mix here given they are largely dedicated to making sure things are submission-ready and absolutely will and should fight this battle if CW isn't following precedent or they feel ISI is being minimized.)
It's important to note that ISI is not an FDA-approved thing in and of itself, only PI is. As far as OPDP is concerned, ISI is just marketing copy presented as fair balance, and technically it can change at any time if the pharma company wants to change it. It's obviously a big red flag if there is different ISI on every piece and it invites scrutiny, but there is leeway to rearrange order of "snippets," fix typos, fiddle with formatting, as long as MLR wills it.