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LTR 139: Steve Silverman on FDA Readiness for QMSR

Let's Talk Risk! Podcast

Published
January 16, 2026
Duration
32:12
Summary source
description
Last updated
Apr 29, 2026

Discusses Summary“QMSR isn’t about regulatory obligation; it’s about managing business risk, protecting custom…

Summary

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 a…

Show notes

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 institu