Sponsors Will Need New Databases And Metrics To Determine Success Of Opioids REMS
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA sees REMS assessment as a collaborative effort and already has initiatives with other federal agencies to find ways to monitor indicators of effectiveness.
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FDA Wants Fast Turnaround In Assessing Opioid REMS' Effectiveness
The agency tells companies to submit proposals in 120 days, and expects to have the REMS in place by the beginning of 2012. The first assessment would be due at six months.
Opioid REMS Could Be Linked To CME, FDA Suggests
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