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# AI is FDA Info Technology Plan’s Top Goal
- URL: https://www.fdaweb.com/ai-is-fda-info-technology-plans-top-goal/
- Published: 2023-09-14T12:00:00.000Z
- Updated: 2026-09-14T18:56:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155331

FDA has made exploring how artificial intelligence (AI) can play a role in its regulatory operations a top strategic goal of its just-released four-year information technology [strategic plan](https://www.fda.gov/media/172067/download?ref=fdaweb.com). It calls for the agency to “(d)rive exploration and address impacts of emerging technologies and trends such as AI and virtual reality on the FDA’s IT portfolio and regulatory operations. Proactively identify opportunities and risks to FDA’s mission and inform responsible use of technology. Enhance partnerships with external experts to leverage these technologies and promptly respond to their impact.”

Under the plan, FDA outlines its AI objectives, such as developing “ethical guidance for technology use while maximizing business value.” It also says the agency will deploy technological innovations (AI/Machine Learning) responsibly with an understanding of “regulatory impacts and effective risk response strategies.”

The plan also calls for FDA to be the thought leader on such emerging technologies by “creating novel use cases for emerging technologies through a deep understanding of business processes, industry, and technology.” The agency will look as well at “harnessing industry expertise and fostering collaboration.” Additionally, the plan says FDA will create an “environment where innovative approaches are encouraged, identified, shared, and evaluated for use in driving operational efficiency and developing new capabilities.”

The use of AI and associated concerns has been receiving considerable FDA attention this year. In March, the agency outlined new potential GMP issues under policy consideration in a [discussion paper](https://www.fda.gov/media/165743/download?ref=fdaweb.com) entitled “Artificial Intelligence (AI) in Drug Manufacturing.” The agency says difficulties could result from “potential ambiguity” on how to apply existing GMP regulations to AI or due to a lack of agency guidance or experience.

The agency said at the time that one area under consideration involves cloud applications that may affect oversight of pharmaceutical manufacturing data and records. “Third-party data management systems could be used for functions that extend beyond data storage,” the paper said. “For example, data stored in these systems may be analyzed by AI to support models for process monitoring and \[advanced process controls\] APC. Data integrity and data quality must be ensured in these environments.”

Additionally, FDA commissioner **Robert Califf** has recently opined on the rapidly advancing AI space (e.g., ChatGPT and other competitors), saying that it is just a matter of time before the agency receives its first “AI-assisted” marketing submission. “The FDA has a talented and influential group of quantitative experts, but to regulate the information-rich, digital world of the future we need to make it a conscious focus,” he said in an [online post](https://www.fda.gov/news-events/fda-voices/work-fda-continues-thousands-workstreams-americans-and-world-count-every-day?ref=fdaweb.com). “An effective organization for knowledge sharing and professional advancement is needed across the multiple professional disciplines with a role in quantitative analysis, data management and computer science.”