The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday released a new report on drug safety priorities from 2018, offering last year’s valsartan contamination fiasco as a good example of how their safety checks work properly.
CDER’s Office of Surveillance and Epidemiology (OSE) is tasked with maintaining a system that can identify and characterize adverse events and medication errors that may not have arisen in the drug development or approval process. Through October 2018, OSE supported more than 6,000 safety reviews across the office’s four core functions: pharmacovigilance, pharmacoepidemiology, medication error prevention and analysis, and risk management.
As part of this work, FDA collects adverse event reports, medication error reports and product quality complaints in a system known as the FDA Adverse Event Reporting System (FAERS), which then can be further monitored via FDA’s Sentinel System.
“We’ll be sharing more soon about our plans for leveraging the possibilities for the Sentinel System to capture real-world data to help in our safety surveillance framework,” CDER Director Janet Woodcock said in a blog post Tuesday…