Posts Tagged ‘ Shuren ’

The FDA’s Internal Employee Struggles

Nov 26th, 2012 | By
The FDA’s Internal Employee Struggles

November 26, 2012 ~ The U.S. Food and Drug Administration (FDA) is a large public agency that regulates consumer products that make up about $1 trillion in annual spending or 25 cents of every dollar spent on food, cosmetics, drugs, medical devices and tobacco products. The Partnership for Public Service supported by the Pew Charitable
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FDA Whistleblower Case Moving Ahead

Nov 13th, 2012 | By
FDA Whistleblower Case Moving Ahead

November 13, 2012 ~Round one in the FDA whistleblower scandal goes to the U.S. Food and Drug Administration. Regulatory Focus (here) reports the FDA had a minor victory November 9, in its case against the National Whistleblower Center (NWC) which is representing five both current and former employees of the FDA who claim they were
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Personal Troubles for FDA’s Dr. Maisel

Aug 7th, 2012 | By
Personal Troubles for FDA’s Dr. Maisel

August 7, 2012 ~ This item  apparently bypassed the desk of MDND. Last month, Deputy Director of the FDA’s Center for Devices and Radiological Health, Dr. William Maisel, was reportedly arrested in a prostitution sting operation in Maryland, according to MassDevice (here). According to the case report here , Dr. Maisel, 46,  was arrested on
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FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

Jun 14th, 2012 | By
FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

If you ask the public, most say they want safer medical devices, not more of them.  If you ask the patients profiled in Mesh Device News Desk (MDND) they’d say they wished they’d known that the medical devices they received had come with a prominent warning that would have told them what they were in
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FDA: What is MDUFA? Hearings on $595 Million and What Industry Wants

Feb 14th, 2012 | By
FDA: What is MDUFA? Hearings on $595 Million and What Industry Wants

February 14, 2012 ~ What is MDUFA? The Medical Device User Fee and Modernization Act shortened from MDUFMA. Enacted in 2002 and again in 2007 it authorized the FDA to collect a user fee from industry to review medical devices before they go on sale. MDUFA in 2010 funded about 20 percent of the medical
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FDA Whistleblowers Sue Agency, Claim Retaliation Over Unsafe Medical Device Revelations

Jan 30th, 2012 | By
FDA Whistleblowers Sue Agency, Claim Retaliation Over Unsafe Medical Device Revelations

January 30, 2012 ~ What’s going on inside the FDA? Six of the “FDA Nine” whistleblowers are suing the agency for illegally spying on their private email claiming they were retaliated against after they warned lawmakers that unsafe medical devices were being approved for market.  You may recall as President Obama was taking office on
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Medtronic Pays $23 Million to Settle Doctor Kickback Charges

Dec 18th, 2011 | By
Medtronic Pays $23 Million to Settle Doctor Kickback Charges

Medtronic is the world’s top maker of medical devices and it didn’t get that way without help. The U.S. Department of Justice accused the Minnesota-based company of having friends in high places – Share this:



Can the FDA Promote Innovation and Protect Patients?

Nov 17th, 2011 | By
Can the FDA Promote Innovation and Protect Patients?

CDRH Shuren Defending FDA Against Harsh Industry Critics Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), was on the hot seat Share this:



WHO ATTENDED: September 8-9 FDA Public/ Expert Meeting on Medical Devices for Obstetrics and Gynecology

Oct 4th, 2011 | By
WHO ATTENDED: September 8-9 FDA Public/ Expert Meeting on Medical Devices for Obstetrics and Gynecology

Synthetic surgical mesh has been on the hot seat of late after a July 13 FDA Safety Communication said that complications are “not rare,” a reversal from an October 2008 Public Health Notification which downplayed side effects as “rare”occurrences. Share this:



FDA Gears Up for Synthetic Mesh Regulation

Sep 11th, 2011 | By
FDA Gears Up for Synthetic Mesh Regulation

SEPTEMBER 10, 2011 – Should synthetic mesh used to treat stress urinary incontinence be upgraded to a Class III high risk device? Share this:



We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.