FDA Seeks Ways To Gauge Real-World Impact Of Abuse-Deterrent Opioids

FDA will hold a two-day public workshop early next month to discuss the regulatory challenges it faces in assessing the real-world, post-market effects of abuse-deterrent opioids, the agency announced Tuesday (June 13). How to capture product-specific exposure data that are not currently collected by clinical trials or the health care system is one hurdle FDA highlights in an issues paper published in preparation for the meeting. Determining the real-world impact of abuse-deterrent opioids is “a key next step in understanding...