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Author: Brenda Fulmer

FDA, Industry Debates 510(k)

06/18/2013
Defective Medical Devices
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The Food and Drug Administration (FDA) held a meeting this week to consider whether the 510(k) approval process for medical devices is keeping the public safe while balancing the need of industry to get innovative products to the market faster and easier. “External stakeholders” were invited and helped set the […]

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FDA Approved Drugs Based on Fraudulent Research

06/18/2013
Articles
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FDA agents have discovered that employees at the Houston office of Cetero Research tampered with records and manipulated test data. This firm has conducted research for drug companies worldwide. Chinna Pamidi, the testing facility’s president, bluntly admitted that much of the lab’s work was fraudulent, saying “You got us” when […]

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Cancer Drug Avastin Linked to Flesh-Eating Bacteria

05/17/2013
Articles
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The controversial cancer treatment drug Avastin (bevacizumab) has one more warning attached to it – the drug has been associated with two deaths and 52 cases of flesh-eating disease. The drug’s maker, Hoffman-LaRoche Ltd., identified the cases of necrotizing fasciitis (flesh-eating bacteria) occurring worldwide from 1997 to 2012.  Both the […]

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Is There a Link Between Crestor and Diabetes?

05/1/2013
Articles
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It has long been suspected that certain types of cholesterol-fighting statin drugs might present a risk for new-onset diabetes mellitus (DM) and that the risk might be dose dependent. Statins are used to prevent heart attacks and strokes by lowering cholesterol. An analysis of clinical trials involving over 113,000 patients […]

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