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REMS Education Paradox: How Can Sponsors Create Independent CME?

Executive Summary

CME content must be developed without influence from drug companies, but FDA says it does not have the resources to write a blueprint for every risk management education program as it did for the opioid REMS.

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REMS Enhancements Could Include Provider Education Credits

FDA draft report on REMS standardization also suggests creating a patient counseling tool template for providers.

Risk Management Professional Society Would Aim To Improve REMS Performance

Initial focus of volunteer industry group of pharmaceutical risk managers is drafting publications which assess the effectiveness of Risk Evaluation and Mitigation Strategies.

Opioid Physician Training Options Remain Limited After Initial Launch

FDA encourages physicians to take advantage of an educational program funded by sponsors of the analgesics as part of the REMS for extended-release opioid products, but only three programs were identified by the March 1 launch date, with Boston University taking the lead.

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