Capitol Hill update: House hearing on FDA and medical devices postponed indefinitely
House Republicans will have to wait another day for their chance to grill CDRH chief Dr. Jeffrey Shuren about the FDA’s “inconsistent application of reasonable standards for safety” in clearing medical devices for market. May 11 Top Selling Webinar – FDA Expectations of Senior Management Save 50% Now with Offer Code 1012199 The House Oversight […]
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GAO renews critique of FDA medical device system
Government investigators say the Food and Drug Administration is putting patients at risk by approving sensitive medical devices such as hip joints and heart defibrillators under the same streamlined system intended for power wheelchairs, stitches and catheters. May 11 Top Selling Webinar – FDA Expectations of Senior Management Save 50% Now with Offer Code 1012199 […]
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FDA’s OK of Perrigo plant signals SOP fixes
The FDA’s all-clear sign for Perrigo’s Michigan manufacturing plant this week is in some ways an understatement of what must have happened there. Inspectors arrived on March 1 and Perrigo announced its “acceptable regulatory status” on Tuesday, six weeks later. May 11 Top Selling Webinar – FDA Expectations of Senior Management Save 50% Now with […]
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FDA opts for “effective remedy” with Triad
The FDA’s seizure of $6 million in products from Triad Group, “to stop Triad from continuing to distribute products which may pose a risk to public health” as the agency says in an announcement, marks the latest step in the entanglement of the two. And it’s not likely to be the last. May 11 Top […]
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