Posts Tagged ‘ IOM ’

FDA Denies Legal Group Seeking to Ban IOM Recommendations

Mar 8th, 2012 | By
FDA Denies Legal Group Seeking to Ban IOM Recommendations

March 7, 2012 ~ Bloomberg BNA reported (here) that the Washington Legal Foundation (WLF), had its petition rejected by the Food and Drug Administration February 21 after the industry-tied group tried to have the recommendation of an expert scientific panel barred from FDA consideration and implementation. The WLF is made up of corporate inside-the-beltway attorneys
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Changes Are Afoot in U.S. Medical Device Regulations, Morningstar, August 15, 2011

Aug 15th, 2011 | By

This excellent article by Morningstar reminds us that the Food and Drug Administration (FDA) has been reviewing the regulatory process that allows most medical devices to make their way into the marketplace and the agency plans to have new changes in place by October. This is sparked by the July release of the Institute of
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Study of Medical Device Rules Is Attacked, Unseen, New York Times, July 27, 2011

Aug 14th, 2011 | By

Allies of the medical device industry criticized an Institute of Medicine report, to be released July 29, that says the approval process for a wide range of medical devices such as hip implants, hospital pumps, surgical mesh and external heart defibrillators is deeply flawed, is injuring patients and causing numerous injuries, reports the New York
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FDA seeks more industry opinion about Device approval process, Star Tribune, August 2, 2011

Aug 13th, 2011 | By
FDA seeks more industry opinion about Device approval process, Star Tribune, August 2, 2011

The medical device industry is very concerned following an Institute of Medicine report that the fast-track system for getting devices on the market should be scrapped, reports the Twin Cities Star-Tribune. Dr. Jeffrey Shuren, who heads the FDA’s device division flew to attend a town hall meeting  with executives to assure them it might not
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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.