Shuren

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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 Read more

By | 2012-11-26T15:34:19+00:00 November 26th, 2012|FDA News|0 Comments

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 Read more

By | 2012-11-13T22:43:22+00:00 November 13th, 2012|FDA News|1 Comment

Personal Troubles for FDA's Dr. Maisel

Dr. William Maisel, Fox TV 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 Read more

By | 2012-08-07T18:26:37+00:00 August 7th, 2012|FDA News|1 Comment

FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

Dr. Jeffrey Shuren, CDRH 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 Read more

By | 2012-06-14T15:58:11+00:00 June 14th, 2012|FDA News|1 Comment

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 Read more

By | 2012-02-14T20:20:15+00:00 February 14th, 2012|FDA News|0 Comments

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 Read more

By | 2012-01-30T23:38:33+00:00 January 30th, 2012|Featured|5 Comments

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 – Read more

By | 2011-12-18T06:11:08+00:00 December 18th, 2011|Media Reports|1 Comment

Can the FDA Promote Innovation and Protect Patients?

Jeff Shuren MD Mesh News Desk, November 7, 2011 ~ 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  Read more

By | 2016-07-05T08:45:53+00:00 November 17th, 2011|FDA News|2 Comments

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

Dr. Thommaso Falcone, Cleveland Clinic Mesh Medical Device News Desk, October 4, 2011~ 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 Read more

By | 2017-04-17T10:06:38+00:00 October 4th, 2011|FDA News|3 Comments