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At Fda A New Goal Then A Push For Speedy Device Reviews - Latest News

FDA’s push for speedy device reviews raises questions

Under Shuren, annual new device approvals ... Lurie said, the FDA has opened the door to lowering its own standards to achieve its goal. The FDA’s struggle to find the right mix of regulation and inno... read more

FDA goal to be "first" on devices worries former regulators

Under pressure from industry, FDA sought to be "first in the world" to approve new medical devices. Former staffers say the FDA's focus on cheaper, faster reviews may put ... Under Shuren, annual new ... read more

Has FDA’s ‘First In The World’ Ambition Contributed To Years Of High-Profile Safety Problems With Medical Devices?

The Associated Press: At FDA, A New Goal, Then A Push For Speedy Device Reviews Dr. Jeffrey Shuren was adamant: The United States would never cut corners to fast-track the approval of medical devices. ... read more

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US Goal to Be 'First' on Devices Worries Former Regulator

Under Shuren, annual new device approvals have more than tripled ... has been used to push approvals through the FDA's pathway for high-risk devices, even in a case where the manufacturer failed to me... read more

FDA's 'flawed' device pathway persists with industry backing

The FDA's move came one day after the publication of a global investigation into medical device safety by more than ... reviews are generally reserved for lower-risk devices that are not truly ... read more

FDA speedy process on devices worries ex-regulators

Under Shuren, annual new device approvals have more than tripled, while warnings to device ... In response to questions from the AP, the FDA said its "first in the world" goal was adopted as part of a ... read more

'Kong: Skull Island' reawakens the monster-movie genre with a mighty roar

Kong is never ridiculous. The same can’t be said for the casting of Tian Jing as a tag-along scientist for no reason better than her name recognition appeal to Asian audiences. Those quibbles aside, l... read more

IMMUNE PHARMS INC (IMNP) CEO Tony Fiorino reviews Corporate Update Conference Call (Transcript)

Since then ... to the FDA that they allow us to run this study in parallel with any other clinical trials such as a pivotal bullous pemphigoid study in order to allow a more speedy path to a ... read more

FOCUS-U.S. regulators snip red tape for medical devices to curb opioid crisis

She now thinks it could be done in months, thanks to a new initiative by the U.S. Food and Drug Administration to use medical device-based ... The FDA told Reuters it has received over 200 submissions ... read more

'I’m Possibly Alive Because It Exists:' Why Sleep Apnea Patients Rely on a CPAP Machine Hacker

CPAP users like Watkins are part of a new push by patients to take control ... their own sleep apnea therapy if they so choose" The FDA, meanwhile, told the Copyright Office at the time that any devic... read more

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