The Zacks Analyst Blog Highlights NVIDIA, Resmed, GE HealthCare and Medtronic
At the forefront of this revolution are players like NVIDIA, whose AI computing platforms are accelerating AI-powered medical ...
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Regulatory hurdles for updating breakpoints for antimicrobial susceptibility test devices: What to know
Finally, manufacturers may only use the PCCP process for breakpoints published on the FDA STIC website, so this process only applies to CLSI breakpoints that the FDA has recognized. Before 2007 ...
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Novelty of PCCP filings a source of drag for FDA, industry
Nick Decker, directory of global regulatory policy for Roch Holding AG’s Roche Diagnostics division, said the FDA is moving carefully into the PCCP space, and industry, too, is taking a measured ...
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FDA delays when a final rule on what foods can be labeled as ‘healthy’ goes into effect
In December, the FDA finalized a rule that updates the nutritional requirements a human food item must meet to claim on its packaging that it is “healthy.” That rule was published with an ...
CNN1mon
FDA’s plan to propose ban on formaldehyde in hair-straightening products remains in limbo under Trump administration
Due to concerns about these chemicals’ links to cancer risks, the FDA under the Biden administration considered proposing a ban on these ingredients in certain cosmetic products such as chemical ...