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FDA Ends Months-Long FOIA Battle Over Medical Device Failures, Says Putting Database Online ‘Satisfies’ KHN Request

The Meals and Drug Administration responded Wednesday to a Freedom of Data Act request filed months in the past, noting that the data sought by Kaiser Well being Information “is now posted on-line.” KHN had filed a collection of FOIA requests, starting in September 2018, in search of hidden experiences …

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FDA Overlooked Red Flags In Drugmaker’s Testing of New Depression Medicine

Ketamine is a darling of fight medics and clubgoers, an anesthetic that may quiet your ache with out suppressing respiratory and a hallucinogenic that may get you excessive with little threat of a deadly overdose. For some sufferers, it additionally has dwelled within the shadows of standard drugs as a …

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More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database

The Meals and Drug Administration has acknowledged that greater than 56,000 never-before-disclosed surgical stapler malfunctions had been quietly reported to the company from 2011 by means of 2018. The newly acknowledged experiences had been detailed in an government abstract for FDA advisers. The company convened a gathering of consultants this …

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Hidden Reports Masked The Scope Of Widespread Harm From Faulty Heart Device

Confronted with the likelihood bout of irregular heartbeats might finish his life, in 2006, Dr. Marc Sicklick had a small gadget implanted in his chest that may shock it again into rhythm. Quickly he would wrestle with one other life-or-death selection: whether or not to take away the Dash Fidelis, …

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FDA To End Program That Hid Millions Of Reports On Faulty Medical Devices

The Meals and Drug Administration introduced it’s shutting down its controversial “different abstract reporting” program and ending its decades-long follow of permitting medical gadget makers to hide hundreds of thousands of studies of hurt and malfunctions from most people. The company stated it should open previous information to the general …

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Health Officials’ Plug For Next FDA Chief: Go Big On E-Cig Regulation

In an nearly uniform response to the upcoming exit of Meals and Drug Administration Commissioner Scott Gottlieb, metropolis and county public well being officers are urging the Trump administration to go larger in its response to adolescents’ rising use of e-cigarettes. The difficulty, they are saying, is reaching disaster ranges …

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FDA Chief Calls For Release Of All Data Tracking Problems With Medical Devices

FDA Commissioner Scott Gottlieb introduced in a tweet Wednesday that the company plans to launch lots of of hundreds, if not tens of millions, of beforehand unpublished damage and malfunction studies tied to about 100 medical units. “We’re now prioritizing making ALL of this knowledge out there,” Gottlieb tweeted. That …

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Device-Safety Experts To FDA: Make Data Public

Medical machine security researchers are calling on the Meals and Drug Administration to launch lots of of 1000’s of hidden damage and malfunction studies associated to about 100 medical units. A latest Kaiser Well being Information investigation revealed that the FDA granted machine makers quite a few “exemptions” from the …

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Analysis: Why Americans Shouldn’t Feel Grateful For $137 Insulin

This month, Eli Lilly and Co. introduced with some fanfare that it was manufacturing a generic model of its personal best-selling insulin model, Humalog, which it could promote for half off — $137.35 versus about $275. David Ricks, the chief govt of Lilly, stated the corporate was making this seemingly …

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FDA Chief Calls For Stricter Scrutiny Of Electronic Health Records

Meals and Drug Administration Commissioner Scott Gottlieb on Wednesday referred to as for tighter scrutiny of digital well being information methods, which have prompted 1000’s of experiences of affected person accidents and different security issues over the previous decade. “What we actually want is a way more tailor-made strategy, in …

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