Citeline Podcasts

This week, "Gray Sheet" reporters discuss FDA's updated 'Refuse To Accept' guidance, the agency's PrecisionFDA platform for next generation sequencing tests, reimbursement updates for drug-coated balloons, the Watchman stroke device, tips from former FDA staffer Cap Uldriks on how to ensure your complaint handling system is healthy and more.

This week, "Gray Sheet" reporters discuss FDA's updated 'Refuse To Accept' guidance, the agency's PrecisionFDA platform for next generation sequencing tests, reimbursement updates for drug-coated balloons, the Watchman stroke device, tips from former FDA staffer Cap Uldriks on how to ensure your complaint handling system is healthy and more.

This week, "Gray Sheet" reporters discuss FDA's updated 'Refuse To Accept' guidance, the agency's PrecisionFDA platform for next generation sequencing tests, reimbursement updates for drug-coated balloons, the Watchman stroke device, tips from former FDA staffer Cap Uldriks on how to ensure your complaint handling system is healthy and more.

Cap Uldriks, a former longtime FDA staffer, offers tips and advice to ensure that medical device manufacturers’ complaint handling system is healthy and stays that way.

FDA's Taha Kass-Hout and David Litwack speak to The Gray Sheet about the agency's plans to launch a beta version of PrecisionFDA that would allow stakeholders to share their knowledge on next-generation sequencing tests and help to advance the science of validating such tests for a spectrum of diseases. Click here for the full article: http://www.thegraysheet.com/a/01150810017

Cap Uldriks, a former longtime FDA staffer, offers tips and advice to ensure that medical device manufacturers’ complaint handling system is healthy and stays that way.

FDA's Taha Kass-Hout and David Litwack speak to The Gray Sheet about the agency's plans to launch a beta version of PrecisionFDA that would allow stakeholders to share their knowledge on next-generation sequencing tests and help to advance the science of validating such tests for a spectrum of diseases. Click here for the full article: http://www.thegraysheet.com/a/01150810017

Cap Uldriks, a former longtime FDA staffer, offers tips and advice to ensure that medical device manufacturers’ complaint handling system is healthy and stays that way.

This week, "Gray Sheet" reporter and editors discuss the FDA's recent robotically-assisted surgical devices workshop; some big news in the obesity device arena including FDA's approval of ReShape Medical’s dual intragastric balloon, along with a PMA submission and a pivotal trial termination from other companies; concerns with overuse of fetal ultrasounds for women with healthy pregnancies and more.

This week, "Gray Sheet" reporter and editors discuss the FDA's recent robotically-assisted surgical devices workshop; some big news in the obesity device arena including FDA's approval of ReShape Medical’s dual intragastric balloon, along with a PMA submission and a pivotal trial termination from other companies; concerns with overuse of fetal ultrasounds for women with healthy pregnancies and more.