MIT, FDA team up on postmarket surveillance
This article was originally published in The Gray Sheet
Executive Summary
Massachusetts Institute of Technology's Center for Biomedical Innovation will work with FDA to explore real-time device and drug safety monitoring, Scott Gottlieb, FDA deputy commissioner for medical & scientific affairs, announced Aug. 17. MIT will identify alternative methods to monitor "well-established" pharmaceutical products and medical devices using "large healthcare datasets to recognize patterns that indicate unexpected efficacy or problems with safety," Gottlieb said. Such systems are currently being used to guard against bioterrorism and pandemics. Current methods to detect adverse events are insufficient, Gottlieb said...