The US Food and Drug Administration (FDA) Commissioner, Dr. Martin Makary, reports that FDA has completed its first pilot using artificial intelligence (AI) in the agency’s scientific review process and has set a timeline of June 30, 2025, to scale up the internal use of AI by FDA.  

“I was blown away by the success of our first AI-assisted scientific review pilot,” said Dr. Makary in a May 8, 2025, FDA press release. “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,” he said.  

Dr. Makary has directed all FDA centers to begin AI deployment immediately (as reported on May 8, 2025), with the goal of full integration by June 30, 2025. The agency says that work will continue to expand use cases, improve functionality, and adapt to the evolving needs of each center after the initial June 30, 2025 deadline, but by that date, all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms. 

FDA is composed of six major centers: the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Tobacco Products (CTP), and the Center for Veterinary Medicine (CVM).  

CDER is the center responsible for regulating over-the-counter and prescription drugs, including new molecular entities (chemically synthesized drugs) and biological therapeutics (i.e., recombinant proteins, monoclonal antibodies, immunomodulators [non-vaccine and non-allergenic products], and certain cytokines and growth factors)  as well as generic drugs and biosimilars. CBER is the center responsible for ensuring the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, tissues, and cell and and gene therapies. 

Looking ahead, FDA says it plans to expand generative AI capabilities across all centers using a secure, unified platform. Future enhancements will focus on improving usability, expanding document integration, and tailoring outputs to center-specific needs while maintaining strict information security and compliance with FDA policy. 

The agency-wide rollout is being coordinated by Jeremy Walsh, the FDA’s newly appointed Chief AI Officer, who previously led enterprise-scale technology deployments across federal health and intelligence agencies, and Sridhar Mantha, who recently led the Office of Business Informatics in CDER. 

This news follows an earlier announcement from FDA in April (April 2025) that called for a plan to phase out animal testing for monoclonal antibodies and other drugs, in part by applying AI. FDA said its animal testing requirement will be reduced, refined, or potentially replaced using a range of approaches, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (so-called New Approach Methodologies or NAMs data). Implementation of the regimen began last month (April 2025) for investigational new drug applications, where inclusion of NAMs data is encouraged, and the plan for implementation is outlined in a recently released roadmap. To make determinations of efficacy, the agency will also begin using pre-existing, real-world safety data from other countries, with comparable regulatory standards, where the drug has already been studied in humans. 

Source: US Food and Drug Administration