Posts Tagged ‘ Maisel ’

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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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.