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

Autor: Neyarapally GA; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, MD, USA. George.neyarapally@fda.hhs.gov., Wu L; Division of Bioinformatics and Biostatistics, National Center for Toxicological Research (NCTR), US Food and Drug Administration (FDA), Jefferson, AR, USA., Xu J; Division of Bioinformatics and Biostatistics, National Center for Toxicological Research (NCTR), US Food and Drug Administration (FDA), Jefferson, AR, USA., Zhou EH; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, MD, USA., Dang O; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, MD, USA., Lee J; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, MD, USA., Mehta D; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, MD, USA., Vaughn RD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, MD, USA., Pinnow E; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, MD, USA., Fang H; Office of Scientific Coordination, National Center for Toxicological Research (NCTR), FDA, Jefferson, AR, USA.

Publikováno v: Drug safety [Drug Saf] 2024 Dec; Vol. 47 (12), pp. 1265-1274. Date of Electronic Publication: 2024 Jul 31.