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Tag Archives: clinical trials

Australia's Version of FDA Lax on Medical Device Safety

By Mesh Medical Device Newsdesk |

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 [continue reading…]

Sound Medical Devices Act- Dems Want FDA to Block Approvals When Similar Device is Recalled

By Mesh Medical Device Newsdesk |

  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) [continue reading…]

Op-Ed: Where Facts Are Few, Experts Are Many, by Amy Gezon

By Mesh Medical Device Newsdesk |

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 [continue reading…]

J & J–Led Vaginal Mesh Group Says FDA Should Require More Studies, Bloomberg, Sept 8, 2011

By Mesh Medical Device Newsdesk |

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 [continue reading…]

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