Abstract: Rock and a Hard Place: Mandated Multi-National Drug Utilization Studies in the Absence of Suitable Secondary Sources of Dataoduct Safety Statistical Analysis Plans

 

Abstract: Rock and a Hard Place: Mandated Multi-National Drug Utilization Studies in the Absence of Suitable Secondary Sources of Dataoduct Safety Statistical Analysis Plans

The objective of this abstract is to describe new evidence requirement challenges imposed by regulators with respect to evaluations of drug safety post-market and discuss logistical challenges and timeline constraints associated with chart review DUS to inform dialogue and negotiations with regulators.