Citeline Podcasts

On this week's podcast, Gray Sheet reporters discuss the Department of Homeland Security's proactive stance on device cybersecurity, tips from FDA on eCopy submissions, reports on device safety and several legal updates.

Could there be more accelerated approvals for drugs outside of oncology? Former FDA rheumatology official Jeffrey Siegel, now a Genentech exec, talks to “The Pink Sheet” journalist Emily Hayes about how his company is targeting areas of unmet need and muses on possibilities for faster approvals in his field. Recorded onsite at the American College of Rheumatology meeting November 10, 2015, San Francisco, CA.

Could there be more accelerated approvals for drugs outside of oncology? Former FDA rheumatology official Jeffrey Siegel, now a Genentech exec, talks to “The Pink Sheet” journalist Emily Hayes about how his company is targeting areas of unmet need and muses on possibilities for faster approvals in his field. Recorded onsite at the American College of Rheumatology meeting November 10, 2015, San Francisco, CA.

Could there be more accelerated approvals for drugs outside of oncology? Former FDA rheumatology official Jeffrey Siegel, now a Genentech exec, talks to “The Pink Sheet” journalist Emily Hayes about how his company is targeting areas of unmet need and muses on possibilities for faster approvals in his field. Recorded onsite at the American College of Rheumatology meeting November 10, 2015, San Francisco, CA.

Reflexion Health CEO Spencer Hutchins spoke to “The Gray Sheet” about the company’s successful clearance of the Vera system to help patients rehabilitate after surgery. He says companies like his in the digital health realm need to make sure they hire regulatory experts and prepare their product for regulatory clearance from the getgo if they hope to get it on the market in the short and medium term.

Reflexion Health CEO Spencer Hutchins spoke to “The Gray Sheet” about the company’s successful clearance of the Vera system to help patients rehabilitate after surgery. He says companies like his in the digital health realm need to make sure they hire regulatory experts and prepare their product for regulatory clearance from the getgo if they hope to get it on the market in the short and medium term.

Reflexion Health CEO Spencer Hutchins spoke to “The Gray Sheet” about the company’s successful clearance of the Vera system to help patients rehabilitate after surgery. He says companies like his in the digital health realm need to make sure they hire regulatory experts and prepare their product for regulatory clearance from the getgo if they hope to get it on the market in the short and medium term.

On this week’s podcast, editors Shawn Schmitt and David Filmore discuss “The Gray Sheet” analysis of where things stand with FDA’s premarket review performance three years in to the MDUFA III user fee program.

On this week’s podcast, editors Shawn Schmitt and David Filmore discuss “The Gray Sheet” analysis of where things stand with FDA’s premarket review performance three years in to the MDUFA III user fee program.

On this week’s podcast, editors Shawn Schmitt and David Filmore discuss “The Gray Sheet” analysis of where things stand with FDA’s premarket review performance three years in to the MDUFA III user fee program.