What Foods Will Be Impacted by FDA’s Ban on Red Dye No. 3—And What Could Replace It
T he U.S. Food and Drug Administration (FDA) banned the use of Red Dye No. 3 in food and ingested drugs on Wednesday, more ...
California Pizza Recall as FDA Issues Highest Risk Warning
What and soy are two of nine major allergens. Others are milk, eggs, sesame, fish, tree nuts, crustacean shellfish and peanuts. Allergy reactions may lead to symptoms like hives, rashes, swelling, ...
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 ...
FDA warns: Why you should be cautious about common cookware that may contaminate food
The FDA warns that certain imported aluminum, brass, and alloy cookware can leach lead into food, posing health risks, ...
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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, ...
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.
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 ...