How Do You Measure Opioid REMS Effectiveness?
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All metrics for assessing the effectiveness of the Risk Evaluation and Mitigation Strategy for long-acting/extended release opioids may not be in place when FDA approves REMS for individual products.
Sliding Scale: Bar For COVID Therapeutics EUAs ‘Can Be Somewhat Variable’ – FDA’s Peter Marks
Marks appeared to use the variable EUA bar to justify what many viewed as early mistakes by FDA during COVID-19, and to emphasize the importance of physician awareness of the strength of evidence used to authorize a drug.