In a recent JAMA article, the FDA outlined its priorities to address delays in the drug approval process, including the use of generative AI to improve efficiency.
On May 8, 2025, the agency launched its first AI-assisted scientific review pilot, using advanced generative AI to conduct initial reviews of application materials, which can exceed 500,000 pages, and generate standardized data tables. Following the completion of the pilot review, Commissioner Makary directed all FDA centers to begin implementing AI-assisted scientific review, with the goal of full deployment by June 30, 2025.
The FDA also plans to modernize how it reviews AI-based medical technologies, with updating this process to support innovation while ensuring safety is identified as a top priority. Learn more here.
Last Updated on June 13, 2025 by Aimed Alliance
