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# Machine Learning Increasingly Important to FDA
- URL: https://www.fdaweb.com/machine-learning-increasingly-important-to-fda/
- Published: 2020-01-15T12:00:00.000Z
- Updated: 2026-09-14T15:58:43.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145857

Eight FDA staffers say they envision that machine learning will play an increasingly important role in future drug development and regulation. Writing in *Clinical Pharmacology and Therapeutics*, they [say](doi:10.1002/cpt.1771) (membership or purchase required) that machine learning “will likely be an essential tool for data aggregation, information synthesis, pattern recognition, and decision optimization. Regulatory agencies will likely receive more submissions using machine learning components, and machine learning will undoubtedly play an important role in facilitating regulatory review and research as well as optimizing operations.”

The authors write that in general, the utilization of machine learning tools should be fit-for-purpose and risk-based. Proper validation of machine learning algorithms is critical to ensure their performance, they say.

The article includes background information on machine learning, examples of machine learning submissions to FDA, and examples of machine learning applications in the agency’s review and research.