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 ...
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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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 ...
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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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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 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 ...
Fact Check: Bovaer’s active ingredient not detected in dairy products
There is no evidence that the active ingredient in Bovaer, an emissions-reducing additive fed to cows, is present in dairy ...
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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’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 Issues Warning About Supplement Containing Potentially Deadly Antidepressant
The FDA also sent a letter to gas stations and convenience ... The Federal Drug Administration has issued a warning against ...
Lost Money on Applied Therapeutics, Inc.(APLT)? Join Class Action Suit Seeking Recovery - Contact Levi & Korsinsky
THE LAWSUIT: A class action securities lawsuit was filed against Applied Therapeutics, Inc. that seeks to recover losses of shareholders who were adversely affected by alleged securities fraud between ...