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# Califf Pushes Improved Evidence Generation System
- URL: https://www.fdaweb.com/califf-pushes-improved-evidence-generation-system/
- Published: 2023-02-24T12:00:00.000Z
- Updated: 2026-09-14T18:17:14.000Z
- Author: David McFarland
- Tags: EIRs/483s, #legacy-id-D5153855

FDA commissioner **Robert Califf** continues to call for better evidence generation and suggests that with the rapidly advancing artificial intelligence (AI) space (e.g., ChatGPT and other competitors) it is just a matter of time before the agency receives its first “AI-assisted” marketing submission. “As we develop much better systems of evidence generation, data science and statistics form the bedrock of generating evidence from data and information,” 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). “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. 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.”

Califf’s post reminisced about his clinical practice days and his recognition of the need for higher-quality evidence generation to “ guide our decisions about health. There is now a consensus among many experts that while the early phases of medical product development could be more efficient, the system basically works. But the evidentiary basis for late phase to post-market evaluation needs to be upgraded to take advantage of the dramatically different information landscape.”

He said a joint project between FDA and the National Institutes of Health will look to develop a standard terminology to describe evidence generation methods. “I’m excited about the opportunity to contribute to a new infrastructure that will enable much more high-quality evidence to inform decisions,” he continued. You’ll hear much more about this during the upcoming year,” adding that FDA chief medical officer **Hilary Marston** is leading the effort that will work across other federal agencies.

Califf’s post also touched on FDA’s continued engagement with Congress to forge a regulatory pathway for lab-developed tests and to adequately regulate dietary supplements under a sought-after registration and listing requirements ([see earlier story](https://www.fdaweb.com/new-ai-tools-will-require-fda-flexibility-califf/)). He also repeated his observation that the agency needs to “tune up our advisory committee system in a way that enables our experts to get the best advice possible.”