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US FDA and industry face challenges on opioid class REMS

This article was originally published in Scrip

Executive Summary

A risk evaluation and mitigation strategy (REMS) for the long-acting opioid drug class should first be tested on a pilot basis, include technologies for tracking diversion and measure the programme's downstream effects, including whether new prescribing restrictions are leading to increased abuse of other prescription or illegal drugs, stakeholders told the US FDA at a two-day public meeting.

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