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Laura LaBrie

Laura LaBrie

Aug 17, 2026

7:12
Uh, how do you evaluate what you see going on with regard to the use of AI by OPDP these days?
7:23
Yeah.
7:23
Thank you.
7:24
So we know that FDA has made statements saying that they are going to be using AI.
7:29
We don't know exactly in what capacity and to how, like, how much they're going to be using it.
7:35
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.
8:00
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

24:05
What do you see as the big issues, the mega issues here?

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