JD Supra16h
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 ...
Richmond16h
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 ...
FDA bans red dye No. 3 from foods, drinks and candy over potential cancer risk
FDA bans red dye No. 3 from foods, drinks and candy over potential cancer risk - Food manufacturers have until January 2027 ...
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 ...
360dx21h
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.
PBS22h
FDA bans red dye No. 3 from foods, nearly 35 years after it was barred from cosmetics because of potential cancer risk
Food and Drug Administration officials granted a 2022 petition filed by two dozen food safety and health advocates, who urged ...
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 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, ...
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 ...
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 ...
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 ...
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 ...