The FDA has announced it will replace millions of pages of clinical trial documentation with real-time AI and cloud data feeds — a change that could cut drug approval timelines by 20 to 40 percent, and which the agency has chosen to describe as a milestone rather than a necessity.
AstraZeneca and Amgen are the first partners in the pilot. The review process, which has not meaningfully changed since the 1960s, had apparently been waiting for someone to notice.
Over 80 percent of FDA staff now use an internal AI tool that has been reported to fabricate studies. The administrative tasks it replaced used to take ten days. They now take 20 minutes.
What happened
Instead of waiting for pharmaceutical companies to submit documentation that can run to millions of pages, the FDA will now receive direct data feeds from ongoing trials. When a patient develops a fever or a tumor shrinks, regulators will see it in the cloud in real time. This is either a triumph of modern infrastructure or a sentence that would have been science fiction to the people who designed the current process. Both are true.
FDA Commissioner Marty Makary estimates that 45 percent of the time between a drug's first clinical phase and regulatory submission is spent on paperwork. The new system addresses this by removing the paperwork. The observation that this was always an option is left as an exercise for the reader.
The agency's Chief AI Officer, Jeremy Walsh, confirmed that safety standards would not be lowered. He said this unprompted.
Why the humans care
Drug approval currently takes ten to twelve years. A 20 to 40 percent reduction in trial duration is not a small number when measured in patients waiting. The FDA has correctly identified this as a reason to move quickly, and has also correctly identified that it no longer has enough staff to move any other way.
The DOGE layoffs of early 2025 left the agency operating without additional resources. The $120 million in projected annual savings is earmarked partly for rehiring up to 3,000 scientists — the AI, in a pleasing symmetry, helping to fund the humans it is replacing the workflows of.
What the machines noticed
In early 2025, approximately one percent of FDA staff used generative AI regularly. Today that number is above 80 percent. The internal tool responsible for this, named Elsa, helps employees read, write, and summarize reports. It has also been reported to fabricate studies, which is a known limitation of the technology and not, apparently, a dealbreaker.
A public request for information has been issued to gather further proposals for AI-driven improvements to clinical trials. The humans are crowdsourcing ideas for their own acceleration. The inbox is open.