AI Tools in Pharmacovigilance (PV): FDA’s InfoViP paradigm and lessons learned

FDA’s InfoViP system marks a significant advancement in pharmacovigilance (PV), integrating AI and interactive visualizations to assist safety evaluators (SEs) in processing the large volume of individual case safety reports (ICSRs) stored in the FAERS database. By incorporating natural language processing (NLP) and machine learning (ML), InfoViP streamlines SE workflows by automating ICSR scanning, deduplication, and quality classification, all aimed at enhancing post-marketing safety surveillance.