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Sixty days just for the FDA to tell you that your application is complete. We're gonna get that down to one day. We're gonna use AI.

All-In PodcastAll-In Podcast · Supercharging a New FDA: Marty Makary on Science, Power &...

“sixty days just for the FDA to tell you that your application is complete.”

11:15 / 11:53

sixty days just for the FDA to tell you that your application is complete. We're gonna get that down to one day. We're gonna use AI. So we've gotta modernize the agency and be more competitive, not just talk about protectionist strategies.

As you think about those work streams in improving the efficiency, turnaround time, how much can you do this on your own versus how much do you need congress to act to pass legislation to support those changes? And are there priorities that you're working with congress on to try and accelerate drug approval timelines that are necessary? So right now we have user fees, which means if you submit an application,

Why this clip

Dramatic efficiency improvement promise (60 days to 1 day) with AI as the solution. Shows concrete reform vision with measurable outcomes that demonstrates how technology can solve bureaucratic delays.

11:15 - 11:5338sConsequences

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What they said next

There is a race, and when we came to office, we were losing that race. We were behind. We were getting clocked by China, by Australia.

8:57 - 31s · Consequences

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That kind of stuff is intolerable when we're competing with China where they're doing phase ones in four weeks. With Australia, that's doing phase ones in six weeks.

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There is a race, and when we came to office, we were losing that race. We were behind. We were getting clocked by China, by Australia.

High-stakes competitive framing with vivid language ('getting clocked') that positions US biotech leadership as under threat. Creates urgency around regulatory reform through international competition lens.

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