Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling

• George A. NeyarapallyUnited States Food and Drug Administration
• Leihong WuNational Center for Toxicological Research
• Joshua XuNational Center for Toxicological Research
• Esther H. ZhouUnited States Food and Drug Administration
• Oanh DangUnited States Food and Drug Administration
• Joann LeeUnited States Food and Drug Administration
• Dharmang MehtaUnited States Food and Drug Administration
• Rochelle Dalsan VaughnUnited States Food and Drug Administration
• Ellen E. PinnowUnited States Food and Drug Administration
• Hong FangNational Center for Toxicological Research