The FDA’s new, same-old food labels demand better obesity solutions
All things considered, it’s at least as likely to make health outcomes worse as it is to make most people healthier.
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Decentralized clinical trials: FDA guidance and the ‘new modus operandi’
The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...
NeuroPace's SWOT analysis: epilepsy device maker's stock poised for growth
NeuroPace, Inc. (NASDAQ:NPCE), a medical device company specializing in neurological disorders with a market capitalization of $439 million, has been making significant strides in the epilepsy ...
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Six months “a very limited window” for medical device shortage flagging
Beta CEO Marcel Botha talks about the FDA’s plans for medical shortage notifications and how Trump’s policies may impact US ...
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FDA's Final Rule for Laboratory Developed Tests
The FDA’s Webinar for Manufacturers and Other Interested Parties - The U.S. Food and Drug Administration (FDA) will host a webinar ...
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FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.