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 ...
healthcarepackaging1d
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 Supra20h
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 ...
Food Safety News3d
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 ...
ABC15 Arizona2d
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 ...
KTVZ5d
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 ...
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, ...
KTVZ6d
FDA issues letter to veterinarians on adverse side effects of Osteoarthritus drug Librela
According to the American Kennel Club, side-effects from the drug Librela included a skin ... “I just wish there was more of like a black box warning surrounding it, more of reflecting the ...
Business Insider5d
Applied Therapeutics, Inc. Sued for Securities Law Violations – Investors Should Contact Levi & Korsinsky for More Information – APLT
After market hours on December 2, 2024, Applied Therapeutics disclosed it received a "warning letter" from the FDA referring to the clinical trial issues underlying the CRL. Applied Therapeutics' ...
pharmaphorum3d
Warning letter adds to Applied Tx run of bad news
Applied Therapeutics has been sent a warning letter from the FDA over a clinical trial of its rare disease therapy govorestat, which was rejected by the agency last week. The letter – addressed ...
360dx1d
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.