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Predicting FDA Safety Alerts and Drug Label Changes: RxSignal Methodological Changes to Improve Accuracy

Predicting FDA Safety Alerts and Drug Label Changes Using Real World Data From Drug Side Effects

We developed the RxSignal system to provide a post-marketing signaling system that could be used as an alerting mechanism for emerging and/or changing drug safety profiles that may result in FDA regulatory action.

Being able to predict when a given drug might trigger higher rates of unfavorable patient outcomes would be a powerful tool to predict regulatory actions, increase patient safety, and lower downstream medical costs.

The updated system described here uses new inclusion and exclusion criteria to focus on key AE types with already demonstrated interest to FDA. RxSignal can be used to quickly process, screen, and alert as FDA releases new data.