clinical trials

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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) [...]

By |2012-03-06T22:52:49-05:00March 6th, 2012|FDA News|0 Comments

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 [...]

By |2012-02-02T18:24:49-05:00February 2nd, 2012|Legal News|0 Comments

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 [...]

By |2011-10-04T04:19:11-05:00October 4th, 2011|Op-Ed|4 Comments

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 [...]

By |2011-09-13T00:49:00-05:00September 13th, 2011|Media Reports|0 Comments