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# AI, RWE in FDA Decisions
- URL: https://www.fdaweb.com/ai-rwe-in-fda-decisions/
- Published: 2025-10-16T12:00:00.000Z
- Updated: 2026-09-14T15:24:18.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5160056

FDA is laying the groundwork for a future where real-world evidence (RWE) and artificial intelligence (AI) work together to deliver better outcomes for patients and more efficient pathways for innovation. That’s the takeaway posted in a [blog](https://hpm.us6.list-manage.com/track/click?u=192e2d8712a743737ce3d003b&id=77abef2768&e=bde275f02e&ref=fdaweb.com) by **Adrienne Lenz**, the principal medical device regulation expert at Hyman, Phelps & McNamara, from two recent agency meetings.

Lenz says that taken together, the meetings “provided a comprehensive discussion of the use of RWE and AI in regulatory decision making.” She says the AI discussions were also relevant to medical device programs and that agency leadership is pushing for a coordinated approach to AI across the Centers.

Panels at the AI meeting said the technology can be used in many ways across the total product lifecycle, and gave examples of areas where it is used now and can be expected in the future.

Four pillars of data were discussed, she says: quality, reliability, representativeness, and access. There was also discussion of data sharing, recognizing challenges due to the competitive nature of industry and intellectual property concerns.

Agency speakers said the technology is moving too quickly for the standard process for releasing guidances, and encouraged more interactive collaboration between FDA and sponsors to ensure that up-to-date information on acceptance of AI models in applications is available.

Lenz concludes her post with a summary written for her by AI based on her meeting notes: “As FDA continues to embrace the evolving landscape of RWE and AI, the message from both meetings is clear: collaboration, transparency, and adaptability are essential. These tools are not just technical innovations, they are catalysts for smarter, more inclusive, and more responsive regulatory decision making.”