US EditionThe Prompt: FDA Plans To Use AI To Speed Up Scientific Review
- The FDA launched a generative AI tool named Elsa on Monday, 2025, at its headquarters to accelerate scientific reviews and identify key inspection targets.
- Elsa's development and early rollout stemmed from an experimental phase aimed at improving FDA efficiency amid staffing cuts and long regulatory deadlines.
- The tool aids FDA employees by summarizing adverse events, comparing labels, generating code for databases, and expediting clinical protocol reviews.
- FDA Commissioner Marty Makary announced that the launch of Elsa was completed earlier than planned and within the allocated budget, attributing this success to the joint efforts of FDA experts from various departments.
- Elsa's launch suggests the FDA is adopting AI to offset resource challenges, but staff voiced concerns over rushed deployment and insufficient safety guardrails.
24 Articles
24 Articles
FDA develops its own AI for clinical reviews, investigations and more
The Food and Drug Administration (FDA) launched a new generative AI tool it hopes will make employees more efficient on everything from clinical evaluations to inspections. The AI is called Elsa, and it was developed in-house to help with reading, writing and summarizing. “As we learn how employees are using the tool, our development team will be able to add capabilities and grow with the needs of employees and the agency,” FDA Chief AI Officer…
FDA’s AI tool for medical devices struggles with simple tasks
A new Food and Drug Administration AI tool that could speed up reviews and approvals of medical devices such as pacemakers and insulin pumps is struggling with simple tasks, according to two people familiar with it.
FDA Launches "Generative AI Tool" * 100PercentFedUp.com * by Danielle
Discover how the FDA's new generative AI tool, Elsa, is set to revolutionize public health operations. From accelerating reviews to enhancing safety assessments, find out how this innovation aims to make a significant impact on efficiency and accountability.
The FDA rolls out its own AI to speed up clinical reviews and scientific evaluations
The FDA has launched the generative AI tool, Elsa, agency-wide to help its employees with everything from clinical reviews to investigations. Sure, we're living in a time of widespread disinformation and pushbacks against science, but why not rush things through with AI? Elsa — yes, weirdly like the snow queen from Frozen — completed a "very successful pilot program with FDA’s scientific reviewers." According to the FDA, the AI tool can help wit…
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