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FDA warns Hologic to do more to prevent harm from component in recalled implant markers
The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...
New Chrome, Safari, Edge Warning—Do Not Buy From These Websites
Last year ended with warnings about malicious websites parting holiday shoppers with their hard earned cash, and 2025 has ...
FDA's Suggested Change to Food Packaging Raises Concerns Among Experts
Newsweek spoke to experts about the FDA's suggestion to place nutrition information on the front of packaged foods.
Hologic receives FDA warning letter over Biozorb implantable markers
Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.
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Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 ...
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FDA bans red dye No. 3 from foods
U.S. regulators on Wednesday banned the dye called Red 3 from the nation's food supply, nearly 35 years after it was barred ...
Marlborough device maker receives FDA warning regarding implantable devices
Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even ...
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FDA Warns Randox Laboratories Over Reagent Carryover Between Assays
The UK-based firm has issued five Class II recalls for its RX-series analyzers since 2018 for issues related to reagent carryover between subsequent tests.
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Appropriate Steps to Avoid And Answer FDA Warning Letters in 2025
The rate of warnings initiated by the FDA continues to rise in the pharma and medical device industries. Knowing how to best ...
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FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research
Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product development, ...
US judge blocks FDA graphic warning label requirement for cigarettes
A federal judge in Texas has blocked the U.S. Food and Drug Administration from enforcing a looming requirement that ...
FDA proposes warning label on front of food packaging to combat obesity epidemic
The FDA proposed a new rule requiring food companies to place front-of-package labels on products indicating sodium, saturated fat, and added sugar content.