AIMC Topic: United States Food and Drug Administration

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Prediction of Drug Approval After Phase I Clinical Trials in Oncology: RESOLVED2.

JCO clinical cancer informatics
PURPOSE: Drug development in oncology currently is facing a conjunction of an increasing number of antineoplastic agents (ANAs) candidate for phase I clinical trials (P1CTs) and an important attrition rate for final approval. We aimed to develop a ma...

Development of an automated assessment tool for MedWatch reports in the FDA adverse event reporting system.

Journal of the American Medical Informatics Association : JAMIA
OBJECTIVE: As the US Food and Drug Administration (FDA) receives over a million adverse event reports associated with medication use every year, a system is needed to aid FDA safety evaluators in identifying reports most likely to demonstrate causal ...