Posts Tagged ‘ Center for Devices and RAdiological Health ’

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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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: Breast Implant Safety Studies Will Continue, Web MD, August 31, 2011

Sep 3rd, 2011 | By
FDA: Breast Implant Safety Studies Will Continue, Web MD, August 31, 2011

Web MD reports the current post-approval studies on silicone-gel implants will continue according to the FDA’s Center for Devices and Radiological Health (CDRH) even though among the original 100,000 women enrolled in the studies, researchers have lost track of up to 79% of the women. That was just three years into a 10-year study. William
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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.