“The Food and Drug Administration is ramping up its efforts to leverage billing, claims, EHR and registry data to better inform the agency’s regulatory decisions regarding drugs and other medical products.”
“This real-world evidence (RWE) could help to “answer questions that are relevant to broader patient populations or treatment settings where information may not be captured through traditional clinical trials,” according to FDA Commissioner Scott Gottlieb, MD…”
“The agency has two active post-market monitoring systems—the National Evaluation System for health Technology (NEST) for medical devices and the Sentinel system for drugs and biologics…”
“When it comes to active surveillance for medical devices, he pointed out that the FDA’s Center for Devices and Radiological Health has made “building out” of NEST one of CDRH’s top priorities…” Read the full article here.
Source: FDA looks to bolster regulatory decisions using real-world data – By Greg Slabodkin, September 4, 2018. HealthData Management.
