Citeline Podcasts

This week, "Gray Sheet" reporters and editors discuss an exclusive interview with FDA's Robert Califf and the agency's ongoing efforts to reform combination product regulations, CMS reimbursements for molecular diagnostic tests, efforts to repeal the medical device tax, earlier than anticipated approval of Edwards Lifesciences' Sapien 3 transcatheter aortic valve system, diagnostics reform, and other device issues in the Senate.

This week, "Gray Sheet" reporters and editors discuss an exclusive interview with FDA's Robert Califf and the agency's ongoing efforts to reform combination product regulations, CMS reimbursements for molecular diagnostic tests, efforts to repeal the medical device tax, earlier than anticipated approval of Edwards Lifesciences' Sapien 3 transcatheter aortic valve system, diagnostics reform, and other device issues in the Senate.

This week, "Gray Sheet" reporters and editors discuss an exclusive interview with FDA's Robert Califf and the agency's ongoing efforts to reform combination product regulations, CMS reimbursements for molecular diagnostic tests, efforts to repeal the medical device tax, earlier than anticipated approval of Edwards Lifesciences' Sapien 3 transcatheter aortic valve system, diagnostics reform, and other device issues in the Senate.

In an exclusive interview with The Gray Sheet, FDA's Robert Califf, spoke about concerns the agency has with regulating combination products, provides tips for companies looking to get combo products to market, clinical trial transparency and whether he'd consider taking on the role of FDA commissioner.

In an exclusive interview with The Gray Sheet, FDA's Robert Califf, spoke about concerns the agency has with regulating combination products, provides tips for companies looking to get combo products to market, clinical trial transparency and whether he'd consider taking on the role of FDA commissioner.

In an exclusive interview with The Gray Sheet, FDA's Robert Califf, spoke about concerns the agency has with regulating combination products, provides tips for companies looking to get combo products to market, clinical trial transparency and whether he'd consider taking on the role of FDA commissioner.

This week, Gray Sheet reporters and editors discuss CDRH's new pediatric chief medical officer, Cohera's Sylys surgical sealant, Cerebral Assessment System's Cognivue early dementia test, Xagenic's novel point-of-care molecular diagnostic platform, Comprehend's cloud-based system for managing clinical trial data, a Q&A with a legal expert about the federal court’s “20-hour" 510(k) position and Bayer’s sale of its diabetes care business to Panasonic Healthcare.

This week, Gray Sheet reporters and editors discuss CDRH's new pediatric chief medical officer, Cohera's Sylys surgical sealant, Cerebral Assessment System's Cognivue early dementia test, Xagenic's novel point-of-care molecular diagnostic platform, Comprehend's cloud-based system for managing clinical trial data, a Q&A with a legal expert about the federal court’s “20-hour" 510(k) position and Bayer’s sale of its diabetes care business to Panasonic Healthcare.

This week, Gray Sheet reporters and editors discuss CDRH's new pediatric chief medical officer, Cohera's Sylys surgical sealant, Cerebral Assessment System's Cognivue early dementia test, Xagenic's novel point-of-care molecular diagnostic platform, Comprehend's cloud-based system for managing clinical trial data, a Q&A with a legal expert about the federal court’s “20-hour" 510(k) position and Bayer’s sale of its diabetes care business to Panasonic Healthcare.

This week Gray Sheet reporters and editors discuss our analysis of 2014 Medical Device recalls, St. Jude's U.S. Portico transcatheter aortic valve trial, an upcoming FDA guidance to address criteria for whether an advisory panel needs to be called, our recently launched FDA Decision Data tables, reactions on how the 21st Century Cures bill provision on advisory panels will change their membership, ongoing work to converge U.S. and Canadian device regulations, and a lot more. Read more at www.thegraysheet.com/a/01150608015