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# Researchers Confirm Increasing AI/ML Role in Drug Development
- URL: https://www.fdaweb.com/researchers-confirm-increasing-ai-ml-role-in-drug-development/
- Published: 2022-06-16T12:00:00.000Z
- Updated: 2026-09-14T17:48:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152094

CDER researchers say their landscape analysis of the application of artificial intelligence (AI) and machine learning (ML) in drug regulatory submissions from 2016 to 2021 confirms an earlier prediction that AI/ML would play an increasingly important role in drug development. Writing in *Clinical Pharmacology & Therapeutics*, the authors [say](https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.2668?ref=fdaweb.com) AI/ML was used to perform a variety of tasks such as informing drug discovery/repurposing, enhancing clinical trial design elements, dose optimization, enhancing adherence to a drug regimen, endpoint/biomarker assessment, and postmarketing surveillance.

The researchers say the trend toward AI/ML applications for drug development is only likely to increase over time. “Both opportunities and challenges lie ahead for the potential uses of AI/ML,” they conclude, “and pharmaceutical and technology companies are actively investing in this area. Moreover, academic researchers are continuing to investigate current and future applications. FDA has also been preparing to manage and evaluate AI/ML uses by engaging with a broad set of stakeholders on these issues and building its capacity in these scientific fields.”