US Food and Drug Administration Shifts to AI-Enhanced Regulatory Review With Elsa 4.0 and HALO.
Journal:
Journal of medical Internet research
Published Date:
May 29, 2026
Abstract
The US Food and Drug Administration recently announced the launch of Elsa 4.0 and Harmonized AI and Lifecycle Operations for Data (HALO)-an upgrade to its artificial intelligence platform. In this News and Perspectives article, JMIR Correspondent Tejas S Athni reports on the evolution of the Elsa model and potential benefits and challenges.
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