FDA’s Red Dye No. 3 Ban, Explained–What It Means For Food & Trust
For decades, FD&C Red No. 3 has added its vivid cherry-red hue to candies and cupcakes—but its risks have been debated just ...
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 over 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 ...
JD Supra1d
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, ...
FDA proposes putting nutrition labels on the front of packaged foods in health push
The U.S. Food and Drug Administration on Tuesday proposed packaged foods requiring a front-of-package nutrition label.
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Get healthy in the new year? Don't fall for weight-loss drug scams
As certain weight-loss drugs have become increasingly popular, scammers are taking notice and coming out of the woodwork to ...
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FDA warns companies about lead contamination and other violations
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
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Update: FDA issues alert to veterinarians warning of adverse side-effects from osteoarthritis drug Librela
KTVZ News has an update Friday on our previous reports about the sometimes tragic results from use of Librela, a once-monthly ...