The U.S. Food and Drug Administration (FDA) has announced a new pilot program that uses artificial intelligence and cloud computing to monitor clinical trials in real time, a move that could significantly accelerate drug approval processes.
Instead of relying on pharmaceutical companies to submit lengthy documentation—often millions of pages—the FDA will now receive direct data feeds from ongoing studies via AI and cloud infrastructure. This shift aims to cut the decade-long timeline for bringing new drugs to market.
FDA Commissioner Marty Makary called the announcement a milestone. “Right now, it takes ten to twelve years to bring a new drug to market, and roughly 45 percent of the time between the first clinical phase and regulatory submission is spent on paperwork and administrative tasks,” he said. “The new pilot program gives the FDA a direct data feed from active trials, so when a patient develops a fever or a tumor shrinks, regulators can see it happening in the cloud in real time.”
Jeremy Walsh, the FDA's Chief Artificial Intelligence Officer, estimates the approach could cut total trial duration by 20 to 40 percent. He emphasized that safety standards would not be lowered. The idea emerged last summer, given that the review process has changed little since the 1960s.
AstraZeneca and Amgen are the first partners in the pilot program. The FDA has also published a public request for information to gather additional proposals for AI-driven improvements to clinical trials.
AI Adoption Surges Amid Staff Cuts
The pilot comes as the FDA operates under deep budget cuts imposed by the Trump administration and the Department of Government Efficiency (DOGE). All consolidation efforts are being carried out without additional staff or resources, following significant layoffs in early 2025. Makary said the annual savings of at least $120 million would fund, among other things, the rehiring of up to 3,000 scientists.
AI adoption at the agency has skyrocketed. In early 2025, only about one percent of FDA staff regularly used generative AI, according to Walsh. Now, that figure exceeds 80 percent. An internal tool called Elsa helps employees read, write, and summarize reports. In early pilot projects, AI reduced administrative tasks that once took ten days down to 20 minutes.
However, several FDA employees told CNN last summer that Elsa regularly fabricates nonexistent studies and misrepresents research data. Walsh acknowledged that Elsa, like many large language models, can hallucinate.