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The Opioid REMS: Health Care Reform, One Class at a Time

This article was originally published in RPM Report

Executive Summary

FDA is planning a spring meeting to discuss next steps in a class-wide Risk Evaluation & Mitigation Strategy for opioids. The outcome will redefine the rules of commercial success in the pain class-and provide a critical case study for how FDA's new regulatory tools may reshape other sectors over time. The good news: there appear to be new opportunities amid the change. The bad: industry is definitely not driving the process.

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