Citeline Podcasts

In this "Gray Sheet" podcast interview, industry insider Steve Niedelman looks in his proverbial crystal ball and tells what quality and regulatory professionals should keep a sharp eye on this year, including FDA's inspectional program alignment, quality metrics, warning letters, third-party supplier programs and risk management.

On this week's podcast, we spoke about progress for FDA Commissioner-nominee Robert Califf, and a committee report critical of companies and FDA policies over duodenoscope infection outbreaks. We also discussed company updates from the JP Morgan Healthcare Conference, a federal preemption update and CDRH's two-year policy agenda.

On this week's podcast, we spoke about progress for FDA Commissioner-nominee Robert Califf, and a committee report critical of companies and FDA policies over duodenoscope infection outbreaks. We also discussed company updates from the JP Morgan Healthcare Conference, a federal preemption update and CDRH's two-year policy agenda.

On this week's podcast, we spoke about progress for FDA Commissioner-nominee Robert Califf, and a committee report critical of companies and FDA policies over duodenoscope infection outbreaks. We also discussed company updates from the JP Morgan Healthcare Conference, a federal preemption update and CDRH's two-year policy agenda.

On this week's podcast, "Gray Sheet" editors and reporters discussed medical device 2015 recall trends and what to look out for in the year ahead on Unique Device Identifiers and combination product reforms. We also talked about business news from NuVasive and Qualcomm and regulatory and legal developments for pelvic mesh devices and hearing aids.

On this week's podcast, "Gray Sheet" editors and reporters discussed medical device 2015 recall trends and what to look out for in the year ahead on Unique Device Identifiers and combination product reforms. We also talked about business news from NuVasive and Qualcomm and regulatory and legal developments for pelvic mesh devices and hearing aids.

On this week's podcast, "Gray Sheet" editors and reporters discussed medical device 2015 recall trends and what to look out for in the year ahead on Unique Device Identifiers and combination product reforms. We also talked about business news from NuVasive and Qualcomm and regulatory and legal developments for pelvic mesh devices and hearing aids.

On this week's podcast, "Gray Sheet" editors and reporters discussed medical device 2015 recall trends and what to look out for in the year ahead on Unique Device Identifiers and combination product reforms. We also talked about business news from NuVasive and Qualcomm and regulatory and legal developments for pelvic mesh devices and hearing aids.

On this week's podcast, London-based Amanda Maxwell, Medtech Regulatory Affairs editor for the Gray Sheet's sister publication Clinica, provides an update and important context on the ongoing effort to significantly reform device and diagnostics oversight in the European Union.

On this week's podcast, London-based Amanda Maxwell, Medtech Regulatory Affairs editor for the Gray Sheet's sister publication Clinica, provides an update and important context on the ongoing effort to significantly reform device and diagnostics oversight in the European Union.