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On September 13, 2023, a manufacturer of radiology software solutions – Annalise.ai – announced that FDA granted a breakthrough...
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On March 10, 2023, the U.S. Food and Drug Administration (FDA) published in the Federal Register a long-awaited final rule to update...
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Happy New Year. To ring in 2023, we can now add sesame to the list of allergens, which means new labels; revisiting marketing claims;...
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On April 11, 2022, the U.S. Food and Drug Administration (FDA) issued an open letter to health care providers reminding them about the...
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The U.S. Food & Drug Administration (FDA) has issued a new warning that adds to the agency's prescribing information when iodinated...
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In response to the U.S. Food and Drug Administration's (FDA's) virtual public workshop on transparency surrounding artificial...
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There was a meaningful update from the U.S. Department of Health and Human Services (HHS) yesterday regarding FDA’s regulation of...
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The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency...
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This morning, September 30, the U.S. Food and Drug Administration (FDA) cleared what the FDA describes as the "first new major...
The U.S. Food and Drug Administration (FDA) has begun to gather and publish a list of medical devices that are enabled through software...
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In a notice published in the Federal Register on August 9, 2021, the U.S. Food and Drug Administration (FDA) announced it will implement...
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The Food and Drug Administration (FDA) has published a recall notice from Eco-Med Pharmaceuticals, Inc., a Canadian company, for certain...
As part of our firm's digital white paper, "Outlook: U.S. Health Care 2021", my colleagues Ari Edelman, Sung Park and I authored a piece...
This week, the Food and Drug Administration (FDA) issued a comprehensive guidance document on the testing and labeling of medical devices...
Following a recent warning from the US Food and Drug Administration (FDA) on the safety of certain ultrasound contrast agents (UCAs)...
Last week, the US Food and Drug Administration (FDA) issued a notice that certain ultrasound contrast agents containing polyethylene...