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The FDA has introduced Elsa, an internal AI tool to review safety data, identify labeling issues, and prioritize inspections, ...
The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...
One of the concerns people have when they hear FDA is using AI in the drug approval process is that many people don't have a ...
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FDA genAI reviews hinge on clarity of dossiers
The FDA's new genAI-assisted scientific review technology, named Elsa, was officially adopted by the agency on 2 June.
FDA Commissioner Dr. Marty Makary is leading a handful of controversial new initiatives to make the drug review process more ...
The FDA has introduced Elsa, an internal AI tool to review safety data, identify labeling issues, and prioritize inspections, potentially speeding up responses to food safety issues like recalls.
Elsa’s launch also came on the heels of Trump’s 2026 budget proposal (PDF), which recommends cutting the FDA’s budget by 4%, including the cutting of 1,940 staff salaries.
FDA Will Use AI to Approve Drugs and Devices Faster The agency launched a large-language model, dubbed Elsa, just last week to streamline operations.