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FDA rushed out agency-wide AI tool—it’s not going well | An agency-wide LLM called Elsa was released weeks ahead of schedule.
An agency-wide LLM called Elsa was released weeks ahead of schedule.
"It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications," the announcement promised. FDA staffers who spoke with Stat news, meanwhile, called the tool "rushed" and said its capabilities were overinflated by officials, including Makary and those at the Department of Government Efficiency (DOGE), which was headed by controversial billionaire Elon Musk. However, after cost-cutting in May, the AI pilot originally developed by the FDA's Center for Drug Evaluation and Research, called CDER-GPT, was selected to be scaled up to an FDA-wide version and rebranded as Elsa.
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