FDA leaders say artificial intelligence has the potential to “radically increase efficiency” when analysing the vast volumes of data—often more than 500,000 pages—that companies submit with their approval applications. Last week, the agency introduced Elsa, an AI language model similar to ChatGPT, that could help prioritize facility inspections, summarize drug safety data, and perform other review-related tasks.
But some experts are skeptical of claims that AI can meaningfully speed the review of complex new drugs and high-risk medical devices. “I think that there is great potential here, but I’m not seeing the beef yet,” said Stephen Holland, a former health adviser to the House Energy and Commerce Committee.
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The FDA’s new priorities include re-evaluating chemicals in the U.S. food supply—a goal that has bipartisan support. “For all additives, the benefit-to-harm balance must be re-evaluated,” the agency leaders wrote.
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As the FDA pushes forward with its ambitious new road map, the balance between faster approvals, public trust, and regulatory rigor will remain under close scrutiny.
