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Report: FDA Rules Allow Device Makers to Hide Adverse Events

fda rules allow device makers to hid adverse events

The U.S. Food and Drug Administration created a program that allows medical device makers to hide adverse events and report them years later, the Star Tribune reported. Doctors and patients [...]

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FDA Approves J&J’s Invokamet XR Amid Invokana Litigation


Johnson & Johnson’s Janssen Pharmaceuticals division announced the U.S. Food and Drug Administration approved its latest Type 2 diabetes drug, Invokamet XR (canagliflozin and metformin extended release). Meanwhile, Invokana lawsuit [...]

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FDA Warns about Opioids, Vascular Patch and Catheter Guides

fda warnings opioids patch catheter

In the last few weeks, the U.S. Food and Drug Administration tackled a number of drug and device warnings and recalls. These include prescription opioid products, the Vascu-Guard patch used [...]

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FDA Approves Bayer’s Essure Study after Adverse Events, Deaths

essure bayer fda study

The U.S. Food and Drug Administration has approved Bayer’s postmarket surveillance study plan for Essure — a permanent birth-control device linked to serious adverse events and deaths. The FDA orders [...]

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Power Morcellator Use Declines after FDA Warning

power morcellator use declines fda

Use of power morcellators dropped significantly after the U.S. Food and Drug Administration warned they could spread cancer, according to a new study. Supporters of the devices said complication rates [...]

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FDA Rejects Xarelto Uncontrolled Bleeding Antidote


Portola Pharmaceuticals recently announced that the U.S. Food and Drug Administration (FDA) did not approve its antidote for uncontrolled bleeding linked to blood thinners including Xarelto (rivaroxaban) and Eliquis (apixaban). The [...]

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