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The Prompt: FDA Plans To Use AI To Speed Up Scientific Review
- The FDA launched a generative AI tool named Elsa on Monday, June 2, 2025, to improve efficiency across its scientific and regulatory operations.
- This launch followed an experimental run in May and urgency due to staffing cuts and pressure to meet deadlines on clinical protocol reviews and inspections.
- Elsa helps with reading, summarizing adverse events, comparing drug labels, generating code for databases, and pinpointing high-priority inspection targets.
- FDA Commissioner Marty Makary announced that the launch of Elsa was completed earlier than planned and within budget, attributing this success to the joint efforts of the agency’s internal specialists. A reviewer highlighted that tasks previously requiring two to three days can now be completed in just six minutes.
- Despite positive reception, concerns remain about Elsa’s error-prone nature and insufficient guardrails, suggesting ongoing refinement will be necessary to ensure security and effectiveness.
27 Articles
27 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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