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# AI Has Usefulness for Pharmacovigilance: Report
- URL: https://www.fdaweb.com/ai-has-usefulness-for-pharmacovigilance-report/
- Published: 2022-05-18T12:00:00.000Z
- Updated: 2026-09-14T17:45:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151842

CDER Office of Surveillance and Epidemiology director **Gerald Dal Pan** and deputy director **Robert Ball** say there is considerable interest in applying artificial intelligence (AI) to pharmacovigilance (PV), and one way to start could be through individual case study reports (ICSRs). Writing in the journal *Drug Safety*, Dal Pan and Ball [say](https://link.springer.com/article/10.1007/s40264-022-01157-4?ref=fdaweb.com) the “performance of current AI algorithms applied to processing and evaluation of ICSRs, while generally not sufficient for complete automation, can likely be applied to improve efficiency, value, and consistency if integrated into a system with a ‘human-in-the-loop’ for careful quality control.”

Their article describes a general framework for considering the readiness of AI for PV with some examples of the application of AI to ISCR processing and evaluation in industry and FDA. Dal Pan and Ball also identify outstanding scientific and policy issues to be addressed before the full potential of AI can be exploited for ICSR processing and evaluation, including approaches to quality assurance of “human-in-the-loop” AI systems; large-scale, publicly available training datasets; a well-defined and computable “cognitive framework”; a formal sociotechnical framework for applying AI to PV; and development of best practices for applying AI to PV.

“Practical experience with stepwise implementation of AI for ICSR processing and evaluation will likely provide important lessons that will inform the necessary policy and regulatory framework to facilitate widespread adoption and provide a foundation for further development of AI approaches to other aspects of PV,” they conclude.