Compliance 360° Part 8: Patient Influence On US FDA’s Enforcement Strategy

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this eighth installment, former FDA investigations branch director Ricki Chase explains how the role of the patient influences FDA's enforcement strategy and discusses the agency's recent industry guidance on benefit-risk factors.

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Patients are playing an ever-increasing role in how US FDA approaches its compliance and enforcement priorities, former agency

Indeed, FDA's Center for Devices and Radiological Health "has been increasingly interested in the patient experience and what role that should play in both regulatory and compliance decisions," Chase says in the eighth installment of Compliance 360°, a podcast series from Medtech Insight

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