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21st Century Cures Act Benefits Big Pharma, Device Makers, Critics Say

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The U.S. Senate has passed legislation intended to speed up Food and Drug Administration drug and device approvals and “cut red tape” at the agency, but critics say it benefits [...]

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Report: FDA Rules Allow Device Makers to Hide Adverse Events

surgeon hands and operating tools

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

pouring pills onto a medical chart

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

Closeup of surgeon hands operating

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

female doctor speaking with a female patient

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

surgeons in the operating room with surgical tools

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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