AI Takes Over FDA Drug Reviews

Metatrend #2: AI & Quantum | Metatrend #4: Longevity, Medicine & Biotechnology

What it is

The US Food and Drug Administration (FDA) is integrating Gen-AI across all its centers by June 30, 2025 to speed up elements of the drug approval process from days to minutes (source). The FDA is the first agency to deploy AI in regulatory science. The internal custom system known as cderGPT aims to reduce the current review time from 6 - 10 months to just days, handling the “non-productive busywork” and giving experts time to focus on more life-saving drug research.

Why it matters

In success, all other US government agencies will follow the FDA’s lead – can’t wait for the consumer- and business-facing agencies like FCC, EPA, FTC, USDA, FAA, OSHA, SEC, and DOT to follow suit!

1. The Need for Better, Faster Regulation

AI-powered drug discovery is accelerating at breakneck speed. AIs are now proposing new life-saving drugs while also developing and testing them in vitro (in the lab). As the chart above demonstrates, while AI can cut down drug discovery and pre-clinical timelines (3 – 6 years), it would be awesome for AI to also cut down the grind of bureaucratic approval (1 – 2 years). Such human-led FDA approvals can be slow—ultimately a potential death sentence disguised as a safety protocol.

"This is a game-changer technology," notes the FDA's Deputy Director, Office of Drug Evaluation Sciences Jin Liu, and he's right, but only if we deploy it at the scale this crisis demands. Every month of delay in modernizing review processes translates to preventable deaths and billions in lost economic value. Kudos to the FDA for their leadership!

2. Setting Global Regulatory Standards

Much of the world often follows the US regulatory lead. History proves that American agencies set global standards, for example:

• The CDC's epidemic training programs now operate in 65+ countries
• NIST's cybersecurity framework guides policy from Japan to Saudi Arabia
• FAA certification standards govern aviation safety globally through 39 bilateral agreements

When the FDA demonstrates that AI-assisted reviews maintain safety while slashing timelines, most all regulatory bodies worldwide will scramble to replicate this model, saving lives not only in the US, but globally.

3. Transforming Healthcare Development

The ripple effects will be extraordinary. For decades, the FDA's risk-averse culture prioritized avoiding blame for approving harmful drugs while ignoring the massive loss of life caused by delayed approvals. This has driven patients overseas for treatments, fueling a massive medical tourism industry.

AI-powered reviews change this calculus entirely. When review times collapse from months to days, breakthrough therapies reach patients exponentially faster. The economic impact cascades through the entire healthcare ecosystem: reduced development costs, accelerated innovation cycles, and most critically, lives saved that would have been lost waiting for bureaucratic processes to crawl forward.

This is a critical step in unleashing the full potential of 21st-century medicine.

Other Key Tech Developments This Week:

1

AI scientist discovers new treatment for dry macular degeneration

2

Waymo completes 10 million robotaxi rides, doubling in five months

3

OpenAI acquires Jony Ive's AI device startup for $6.5B, targeting beyond-screen experiences

Until next time,

Peter