The FDA has launched its own generative AI tool named ELSA, aimed at improving operational efficiency while reducing the workload for its employees. The launch came ahead of schedule and under budget, with ELSA designed to assist in various tasks, such as scientific reviews and operational processes, without using regulated industry data to protect sensitive information. ELSA is hosted on Amazon’s GovCloud and can help with reading, writing, and summarizing tasks, as well as generating codes for nonclinical applications.
Early users have praised ELSA for significantly reducing the time needed for clinical protocol reviews and scientific evaluations. However, concerns about AI-related “hallucinations”—instances of inaccurate or misleading outputs—were raised, highlighting the importance of human oversight in ensuring the reliability of AI-generated data.
Despite the technology’s promise, the FDA’s recent layoffs of 3,500 employees, including scientists and testing staff, have led to concerns about the agency’s reliance on AI. The FDA plans to expand ELSA’s capabilities to further support its missions as the tool matures.
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