Gottlieb: FDA To Extend REMS Used For Extended-Release Opioids To Immediate-Release Versions

By Beth Wang / July 11, 2017 at 11:45 AM

For the first time, FDA will extend the regulatory requirements under the Risk Evaluation and Mitigation Strategies (REMS) plan for extended-release opioids to apply to immediate-release opioids, FDA Commissioner Scott Gottlieb announced Monday (July 10) during the agency's public two-day workshop on evaluating the postmarket impact of abuse-deterrent opioids.


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