Get Ready for AI Assisted FDA Inspections Part 2/3

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04/30/2026

Photo By Aaron Burden on Unsplash

Last week, we had a look at the US Food and Drug Administration’s (FDA) launch of their new Artificial Intelligence (AI) tool: Elsa, a large language model-powered (LLM) AI tool capable of reading, writing, and summarizing information. Even though this AI tool was announced less than a year ago, already internal agency data states that 70% of FDA staff are voluntarily using it.   

In addition to the launch of Elsa, in a press announcement on December 1, 2025, the FDA broadcasted the deployment of Agentic AI capabilities for their employees. Agentic AI is unique from LLM AI due to its capability to plan, reason, and execute multi-step actions in order to achieve a specific goal. This means it can be used to assist with more complex tasks such as meeting management, pre-market reviews, review validation, post-market surveillance, inspections and compliance and administrative functions. To demonstrate these capabilities, the FDA launched a two-month Agentic AI Challenge for the agency’s staff to build solutions for previously mentioned complex tasks and show them off at the 13th Annual Scientific Computing Days Symposium; Moderator: Food and Tech Panel Session in January 2026. The leap from the deployment of Elsa to Agentic AI in just under seven months is a testament to how fast AI technology is being developed, innovated, and adopted and why it is essential for agencies like FDA to stay up to date with these changes.

Getting inspection ready for an AI assisted FDA inspection can also look like reaching out to and working with a clinical trial consulting and training firm like Clinical Pathways. Our inspection readiness consulting services break down the FDA inspection process so that you or your company know what to expect during an inspection as well as what to prepare ahead of time and proper etiquette to follow during the inspection. This includes inspection readiness meetings to knowledge map and storyboard your study/trial, mock inspections to give staff a chance to respond to questions similar to those the FDA may ask, and post inspection support such as writing responses to inspectional observations or creating corrective and preventative action plans. For a full list of services, visit our website and see the online store and course catalog. While you are there, make sure to sign up for our free newsletter and blog to receive clinical trial related news such as this. Keep an eye out next week as we finish this 3-part series on the FDA’s use of AI where we will review the recent publication from the FDA: “Artificial Intelligence for Drug Development” as well as CDER and CBER’s collaboration with the EMA: “Guiding Principles of Good AI Practice in Drug Development”.

-The Clinical Pathways Team

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