Seeking Guidance On Abuse-Deterrence: Sponsors Fall Short, Congress Urges Action
This article was originally published in RPM Report
Executive Summary
Congressional appropriators are urging FDA to move quickly to finalize guidance on abuse deterrence claims for opioids—and to take the next step and prohibit marketing of products that don’t deter abuse. FDA says the science isn’t there yet, and two sponsors join the list of those who have failed to clear the hurdle.