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www.fdanews.com/articles/179833-fda-plans-to-require-rems-for-opioid-painkillers

FDA Plans to Require REMS for Opioid Painkillers

December 28, 2016

The FDA plans to require risk evaluation and mitigation strategies for opioid analgesics — including immediate, extended-release and long-acting formulations — to ensure the benefits outweigh the risks of misuse, abuse, addiction, overdose and death.

As a first step, CDER plans to hold a meeting in January 2017 to develop the REMS program, and to discuss the result of a meeting earlier this year of two FDA advisory committees.

According to CDER Director Janet Woodcock, the agency will be considering adding immediate release opioids to the REMS program already in place for extended-release and long-acting opioid painkillers.

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