The FDA has launched “Elsa,” an AI initiative aimed at streamlining scientific review processes, following a directive from Commissioner Makary to fully integrate AI by June 30, 2025. Elsa enhances efficiency by reducing lengthy review tasks to mere minutes, facilitating adverse event summaries, label comparisons, clinical protocol reviews, and safety assessments. This generative AI tool promises to minimize time-consuming, repetitive tasks, thus expediting the approval of new therapies—an effort alongside the FDA’s initiative to phase out animal testing. Powered by large language models in a secure GovCloud environment, Elsa ensures data privacy without leveraging industry-submitted data. The FDA emphasizes that AI will continue to shape regulatory practices, highlighted by two draft guidance documents released earlier this year on AI-enabled software and drug submissions. McDermott will monitor the implications of this AI rollout on review times and regulatory processes. For inquiries, contact McDermott’s Food, Drug & Medical Device Regulatory Group.
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