Drugs

FDA Deploys New AI Tool Under Efficiency Scheme

FDA says it has deployed advanced “agentic AI” capabilities to all agency employees, marking a major expansion of its artificial intelligence (AI) tools for regulatory and scientific work. According to the agency, Agentic AI systems are designed to plan, reason, and execute multi-step tasks autonomously while incorporating human oversight to ensure reliable results. The tools, which staff use voluntarily, can assist with complex workflows including pre-market reviews, post-market surveillance, inspections, compliance tasks, administrative functions, and meeting management, it says.

“Expanding our use of AI puts the best possible tools in the hands of our reviewers, scientists and investigators,” FDA commissioner Marty Makary is quoted in a release as saying. “There has never been a better moment in agency history to modernize with tools that can radically improve our ability to accelerate more cures and meaningful treatments.”

The rollout follows an earlier deployment in May of Elsa, a large language model-based AI tool, which has been voluntarily used by over 70% of FDA staff, Makary says. Agency teams have refined Elsa since its introduction to better integrate it into day-to-day operations.

As part of the new rollout, the FDA is launching a two-month “Agentic AI Challenge” in which employees can develop AI solutions and showcase them at the FDA Scientific Computing Day in January 2026.

The AI models operate entirely within a high-security GovCloud environment, ensuring that sensitive research and data handled by the FDA are protected, Makary says, adding that the models do not train on input data or any data submitted by regulated industries.

The new deployment represents a key step in FDA’s ongoing plan to embed AI across workflows and enhance operational efficiency across the agency.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome