
Laura LaBrie
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Aug 17, 2026
FDA Legal, Regulatory & Compliance Issues, Part 3: Advertising & Promotion
7:24
7:29
7:35
8:00
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7:12Wayne PinesHOST
Uh, how do you evaluate what you see going on with regard to the use of AI by OPDP these days?

Laura LaBrieGUEST
So we know that FDA has made statements saying that they are going to be using AI.

Laura LaBrieGUEST
We don't know exactly in what capacity and to how, like, how much they're going to be using it.

Laura LaBrieGUEST
But we can tell based on these letters, you know, how quickly they're coming, how alike they are, how, you know, for la-lack of a better term, robotic they seem, that, uh, you know, it's safe to assume they're using AI to write the letters and also likely to be reviewing these 2253 submissions that companies have to provide before putting out promotional pieces.

Laura LaBrieGUEST
So thinking through the different ways that AI could be used, um, either by marketers or by OPDP is really an interesting question here, because you have to think through how AI might be used to look at these submissions.
16 MINS LATER