USA – FDA modernizing pharmacovigilance oversight with AI tools

To modernize its pharmacovigilance efforts, the US Food and Drug Administration (FDA) Office of Surveillance and Epidemiology (OSE) is using artificial intelligence (AI) to support the review of adverse event reports and is also piloting the standardization of Risk Evaluation and Mitigation Strategies (REMS) data to make it easier to use, said OSE Deputy Director Robert Ball.

Speaking at DIA’s Global Pharmacovigilance and Risk Management Strategies Conference in Baltimore, MD, Ball said that OSE launched its Information Visualization Platform (InfoViP) an AI-based decision tool in 2022 to help the agency respond to the growing number of adverse event reports. The FDA receives more than 2 million reports a year, and this number is increasing every year. With these reports, FDA must decide whether to generate safety signals for marketed drugs.

Ball explained that “it is a very manual process and [involves] multiple steps with human interactions, and it is challenging for us in generating all the safety information that has to be processed.”…