What are the FDA’s expectations regarding data collection and auditing for the ER/LA Opioid Analgesics REMS?

Published Date: 
October 29, 2013

The FDA has mandated that the REMS Program Companies (RPC) report to the FDA on the progress of implementing the ER/LA Opioid Analgesic REMS and that there be an independent audit of REMS-compliant accredited CE activities to confirm that the education has met the FDA requirements. The FDA has agreed that accrediting bodies can serve as the independent auditors. ACCME will report data about REMS-compliant CE activities that are commercially supported by the RPC to a third-party data aggregator, which will then forward the aggregated information to the FDA as evidence of the reach and impact of RPC-funded, REMS-compliant education. 

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