The U.S. Food and Drug Administration (FDA) has announced the rollout of agentic artificial intelligence (AI) tools for all agency employees, signaling a shift toward more advanced AI use in the life sciences sector.
According to an FDA press release issued December 1, “Agentic AI refers to advanced artificial intelligence systems designed to achieve specific goals by planning, reasoning, and executing multi-step actions. These systems incorporate built-in guidelines — including human oversight —to ensure reliable outcomes.”
As part of this initiative, the FDA is holding a two-month Agentic AI Challenge where staff will develop and present agentic AI solutions at the upcoming FDA Scientific Computing Day in January 2026.
Industry experts are also examining these developments. At the Jeffries Global Healthcare conference in London, Chris Meier, managing director and partner at Boston Consulting Group (BCG), described agentic AI as “more sophisticated, integrated algorithms than standard AI systems.” He explained that such systems often stack several large language models (LLMs) to handle complex tasks like statistical analysis or provide deeper insights compared to traditional AI.
The FDA’s announcement stated that deploying agentic AI “will enable FDA staff to further advance the use of AI to assist with more complex tasks, such as meeting management, premarket reviews, review validation, postmarket surveillance, inspections and compliance and administrative functions.”
BCG has developed a multiagent AI system for a pharmaceutical company aimed at streamlining medical writing for clinical trial protocols. The tool was designed to reduce time needed for first drafts while maintaining regulatory standards. BCG reported that “[t]he in-house senior medical writers have given the new approach their seal of approval, judging that no scientific rigor is lost during the process.” A study sponsored by BCG found that off-the-shelf LLMs can create initial drafts of protocols and related documents reasonably well; further customization improves quality.
Daiichi Sankyo is another company exploring agentic AI applications. Dr. Michael Zaiac, head of Medical Affairs Oncology for Europe and Canada at Daiichi Sankyo, told BioSpace that their use of agentic or generative AI focuses on improving responses to patient and healthcare practitioner queries rather than reducing staff numbers. The company partnered with BCG to integrate these technologies into legacy platforms like Veeva.
Looking ahead, Daiichi Sankyo plans next year to expand its use of agentic AI into content creation for internal training materials and market access dossiers as well as support functions within medical and regulatory affairs such as protocol writing. Currently used in Europe and Canada, there are discussions about expanding adoption in other regions including the U.S., Japan, and Asia Pacific markets.
Dr. Zaiac noted that companies in highly regulated industries remain cautious about adopting new forms of automation: “We embrace novelties, but not just for the purpose of the novelty,” he said. Before launching its program Daiichi Sankyo spent six weeks developing code followed by nine months consulting with legal teams on compliance issues. “We had to really think through what the implications of this could be,” he added.
