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# FDA Needs AI Standards: Executive
- URL: https://www.fdaweb.com/fda-needs-ai-standards-executive/
- Published: 2019-11-07T12:00:00.000Z
- Updated: 2026-09-14T15:52:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145453

Unlearn.AI founder and CEO **Charles Fisher**, whose company uses artificial intelligence (AI) to streamline clinical trials and make them more efficient, says FDA should be moving to set standards for using AI in drug development. Writing in a *Stat* online [post](https://www.statnews.com/2019/11/07/artificial-intelligence-drug-development-fda-standards-needed/?ref=fdaweb.com), Fisher says that AI “can improve efficiency and outcomes in drug development across therapeutic areas.” He says companies are developing AI technologies that hold the promise of preventing serious adverse events in clinical trials by identifying high-risk individuals before they enroll. And, he says, clinical trials could be made more efficient by using AI to incorporate other data sources, such as historical control arms or real-world data.

However, he cautions, misapplication of the technologies can have unintended harmful consequences. Even well-intentioned researchers can develop machine learning algorithms that exacerbate bias, Fisher writes.

FDA has already issued several proposals around regulation of AI products, he says, and has an opportunity to build on those efforts. CDRH has reviewed and cleared a few devices that use AI and has released a proposed framework for artificial intelligence and machine learning in software as a medical device.

“These proposals, though, don’t necessarily apply to AI-based tools used as part of the drug development process,” Fisher writes. “As a result, biopharmaceutical and technology companies aren’t sure how these tools fit into current regulatory frameworks.”

According to Fisher, the agency has an opportunity to ease regulatory uncertainty by proposing a framework that guides how sponsors can use AI tools within drug development programs. “By engaging with industry to develop a workable regulatory framework,” he says, “FDA can balance the opportunity for artificial intelligence to provide significant public health benefits with its mission to protect public health by ensuring that these new technologies are quite reliable. At the same time, FDA could create a pathway for formal qualification of AI-based drug development tools to ensure that these tools are sufficiently vetted. In addition, it could encourage the exploratory use of AI-based technologies in drug development that would allow sponsors and regulators to better understand their advantages and disadvantages through use of new regulatory pathways….”