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LTR 139: Steve Silverman on FDA Readiness for QMSR

Summary

“QMSR isn’t about regulatory obligation; it’s about managing business risk, protecting customers, and preserving market share.”

In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal is joined by Steve Silverman to explore a question that’s often left unspoken: Is the FDA ready for QMSR?

Drawing on his experience as a former FDA leader and industry policy expert, Steve acknowledges that the current environment inside the agency is marked by workforce reductions, loss of institutional knowledge, and political disruption. But he also emphasizes that QMSR activation on…

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