US FDA Needs ‘More Streamlined’ REMS Enforcement Authority, Inspector General Says
Additional power would allow the agency to punish 'simple' REMS violations and improve administration of risk management programs, according to a new report looking at FDA's oversight of opioids.
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US FDA is once again asking whether its opioid Risk Evaluation & Mitigation Strategy program for opioids should make continuing education requirements mandatory for prescribers. This time there may be no choice but to move forward with the plan.
US FDA will incorporate performance goals for reviewing REMS methodological approaches and study protocols as part of PDUFA reauthorization.
Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.