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

27 Mar 2017

• By Shawn M. Schmitt

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.

Other Compliance 360° Podcasts

Handling Difficult US FDA Investigators

Patients are playing an ever-increasing role in how US FDA approaches its compliance and enforcement priorities, former agency investigations branch director Ricki Chase says.

Indeed, FDA's Center for Devices and Radiological Health "has been increasingly interested in the patient experience and what role that...