Posts Tagged ‘ clinical trials ’

Australia’s Version of FDA Lax on Medical Device Safety

Mar 6th, 2012 | By
Australia’s Version of FDA Lax on Medical Device Safety

With the global news about the defective French breast implants called PIP filled with industrial silicone, the Canberra Times (here), published in the capital city of Australia, takes a look at how medical devices reach the market there. Australia’s version of the U.S. Food and Drug Administration (FDA) is called the Therapeutic Goods Administration (TGA)
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Sound Medical Devices Act- Dems Want FDA to Block Approvals When Similar Device is Recalled

Feb 2nd, 2012 | By
Sound Medical Devices Act- Dems Want FDA to Block Approvals When Similar Device is Recalled

  February 1, 2012 ~ Bloomberg reports on a bill  introduced this week that would put the brakes on the approval of a medical device that claims to be similar to another approved device that’s been recalled or found to be defective. The bill was introduced by Democratic lawmakers including Rep. Edward Markey (D-MA) on
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Op-Ed: Where Facts Are Few, Experts Are Many, by Amy Gezon

Oct 4th, 2011 | By
Op-Ed: Where Facts Are Few, Experts Are Many,  by Amy Gezon

Where Facts are Few, Experts are Many: The rise of synthetic mesh for the treatment of stress incontinence during an era of bad science.-  Amy Gezon The United States Food and Drug Administration convened in Gaithersburg, Maryland on September 9, 2011 to discuss the future of synthetic mesh products used for the treatment of stress
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J & J–Led Vaginal Mesh Group Says FDA Should Require More Studies, Bloomberg, Sept 8, 2011

Sep 13th, 2011 | By
J & J–Led Vaginal Mesh Group Says FDA Should Require More Studies, Bloomberg, Sept 8, 2011

This article in Business Week (here)  reports that medical device makers attending a September 8 & 9 panel of experts convened by the Food and Drug Administration (FDA) over the use of synthetic mesh in women with pelvic and incontinence problems agreed on the need for more safety studies, however they proposed new versions of
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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.