Other Compliance 360° Podcasts
- Handling Difficult US FDA Investigators
- Getting The Most Out Of Inspection Close-Out Meetings
- Building Trust With US FDA – Can It Be Done?
- How To Better Manage Your Quality Data
- Medical Device 483s – US FDA’s Top 5 Observations
- Don’t Do That! How To Respond To FDA-483s
- Factors Feeding Your Inspection Cycle – A New Paradigm
- Patient Influence On US FDA’s Enforcement Strategy
- US FDA Is Looking Closely At Process Validation – Are You Ready?
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 should play in both regulatory and compliance decisions," Chase says...
