Panna Sharma, CEO of Lantern Pharma, commented on the U.S. Food and Drug Administration’s launch of its new AI tool in PharmaVoice, stating: “The timeline is aggressive, especially given that the scope and rigor of the initial pilot testing wasn’t fully showcased, but this reflects the urgency FDA feels.” His remarks highlight the rapid pace at which the agency is moving to integrate artificial intelligence into its regulatory infrastructure.
The FDA officially announced the agency-wide deployment of Elsa, a generative AI tool designed to assist staff in reviewing clinical protocols, summarizing adverse events, comparing drug labels, and identifying inspection targets. Developed within a secure GovCloud environment, Elsa does not train on data from regulated industry, ensuring confidentiality and data integrity. FDA Commissioner Marty Makary said the rollout was completed ahead of schedule and under budget, calling it a key step in the agency’s broader push to enhance efficiency through advanced technologies.
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