After 3+ years, US FDA finalizes strict ER/LA opioid REMS
This article was originally published in Scrip
Executive Summary
Highlighting the ongoing "crisis" in the US of the misuse and abuse of extended-release (ER) and long-acting (LA) opioids, such as oxycodone products, like Purdue Pharma's OxyContin, the head of the US FDA on 9 July unveiled the final risk evaluation and mitigation strategy (REMS) plan for which makers of those products must comply – a development program that has been in the works for more than three years.