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Report From FDLI Annual Meeting: FDA’s Expanding Use Of AI – What Regulated Industry Should Know
The FDA is rapidly deploying artificial intelligence across its regulatory operations, from application reviews to enforcement actions. Agency officials revealed at the 2026 FDLI Annual Conference how AI tools like Elsa 4.0 and HALO are transforming everything from FOIA processing to inspectional planning. These developments raise critical questions about data protection, inter-sponsor firewalls, and the accuracy of AI-generated regulatory decisions that life sciences companies must now navigate.
Skadden Arps Slate Meagher & Flom