The FDA announced it will broaden the existing Risk Evaluation and Mitigation Strategy (REMS)—which currently only covers extended-release/long-acting (ER/LA) formulations—to apply to immediate-release (IR) opioids as well.
“By putting in place safety measures for IR opioid analgesics, and creating a more robust path to converting the high-dose opioids to formulations that are more resistant to manipulation, we are addressing both ends of this crisis,” wrote FDA