The US Food and Drug Administration (FDA) has announced that all its centres will operate on a common generative artificial intelligence (AI) system by 30 June this year.
The “aggressive” rollout timeline follows the successful completion of a new AI-assisted scientific review pilot, the regulator said.
The AI tools will be deployed immediately and will expedite the review process by enabling FDA scientists and subject-matter experts to spend less time on “tedious” and “repetitive” tasks.
FDA commissioner, Martin Makary, said: “We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process.
“The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.”
The rollout will be led by Jeremy Walsh, who was appointed as the regulator’s chief AI officer just days ago. Walsh will be joined by Sridhar Mantha, director of the Center for Drug Evaluation and Research (CDER)’s Office of Strategic Programs.
After the secure system is fully integrated, work will continue to improve the technology’s usability, expand document integration and adapt to the needs of each centre, while maintaining information security and compliance with FDA policy.
“There have been years of talk about AI capabilities in frameworks, conferences and panels but we cannot afford to keep talking. It is time to take action. The opportunity to reduce tasks that once took days to just minutes is too important to delay,” Makary said.
Significant advancements have been made in AI over recent years and the technology is being increasingly applied across multiple industries, including healthcare.
According to the FDA, AI is being used more frequently throughout the drug product life cycle and across a range of therapeutic areas, and the CDER has seen a significant rise in the number of drug applications using AI components.
The regulator also promotes the development of medical devices that incorporate AI and machine learning.