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.
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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.
The struggles that industry and FDA face when trying to best standardize and evaluate REMS are illustrated by the dozens of topics jammed into the two-day meeting.
The agency cited the forthcoming guidance in response to an HHS Inspector General report that questions the effectiveness of the risk management program.