Citeline Podcasts

On this week's podcast, "Gray Sheet" journalists talk about a new Smart template FDA is rolling out to guide 510(k) reviews, the agency's shift in approach to encourage a "critical-to-quality" focus by companies, recent Government Accountability Office findings on device postapproval studies and what CDRH chief Jeff Shuren has to say about FDA versus EU regulations.

On this week's podcast, "Gray Sheet" journalists talk about a new Smart template FDA is rolling out to guide 510(k) reviews, the agency's shift in approach to encourage a "critical-to-quality" focus by companies, recent Government Accountability Office findings on device postapproval studies and what CDRH chief Jeff Shuren has to say about FDA versus EU regulations.

On this week's podcast, the "Gray Sheet" team spoke about who has filled a newly established FDA position overseeing the device inspections program, the removal of a warning letter from the agency's website tied to an off-label marketing suit, what 23andMe addressed with FDA to relaunch a slimmed down direct-to-consumer genetic testing service after a two-year hiatus, bioabsorbable stents and more.

On this week's podcast, the "Gray Sheet" team spoke about who has filled a newly established FDA position overseeing the device inspections program, the removal of a warning letter from the agency's website tied to an off-label marketing suit, what 23andMe addressed with FDA to relaunch a slimmed down direct-to-consumer genetic testing service after a two-year hiatus, bioabsorbable stents and more.

On this week's podcast, the "Gray Sheet" team spoke about who has filled a newly established FDA position overseeing the device inspections program, the removal of a warning letter from the agency's website tied to an off-label marketing suit, what 23andMe addressed with FDA to relaunch a slimmed down direct-to-consumer genetic testing service after a two-year hiatus, bioabsorbable stents and more.

Boston Scientific's Craig Thompson says he's not as confident in fully bioabsorbable drug eluting stents to reduce late-stage complications and discusses ongoing work to expand the indication for the company's newly approved Synergy bioabsorbable DES.

Boston Scientific's Craig Thompson says he's not as confident in fully bioabsorbable drug eluting stents to reduce late-stage complications and discusses ongoing work to expand the indication for the company's newly approved Synergy bioabsorbable DES.

Boston Scientific's Craig Thompson says he's not as confident in fully bioabsorbable drug eluting stents to reduce late-stage complications and discusses ongoing work to expand the indication for the company's newly approved Synergy bioabsorbable DES.

“The Gray Sheet” talks to FDA's Bram Zuckerman at TCT 2015 in San Francisco about his decades-long experience at the agency, the future of cardiac devices and why some companies are hesitant about talking to FDA early on about their product development

“The Gray Sheet” talks to FDA's Bram Zuckerman at TCT 2015 in San Francisco about his decades-long experience at the agency, the future of cardiac devices and why some companies are hesitant about talking to FDA early on about their product development