The U.S. Food and Drug Administration announced a bold new step in its effort to modernize how it evaluates medicines, medical devices, and other health products: it will start using "agentic" artificial intelligence. In a press release on Dec. 1, the agency explained that AI‑driven agents will help staff tackle complex, time‑consuming tasks such as organizing meetings, conducting pre‑market reviews, monitoring products after they hit the market, and even performing inspections. The move follows a promise made by FDA official Marty Makary in May to fully embed generative AI into the agency’s workflow by the end of June. To kick off the initiative, the FDA introduced "Elsa," a large‑language‑model chatbot designed to speed up the review process by quickly summarizing data, flagging safety concerns, and drafting routine documents. Officials say the technology will act as a collaborative partner—not a replacement for human expertise—allowing regulators to focus on high‑impact decisions while the AI handles repetitive analysis. The agency hopes the new tools will cut review times, improve post‑market surveillance, and ultimately get safe, effective treatments to patients faster. As the FDA pilots these AI agents, it will also develop safeguards and oversight procedures to ensure transparency, accuracy, and accountability throughout the process.
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