In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
The crackdown comes as the FDA has scaled back enforcement in recent decades. The agency once sent more than 100 warning letters annually to pharmaceutical companies for misleading advertising but ...
A Johnson & Johnson innovate medicine subsidiary, Janssen Vaccines, landed in hot water with the FDA this summer over a 2024 inspection of the company’s production facility in South Korea. In a ...
Cdymax Pharma has been slapped with a warning letter from the FDA outlining two observations against the Bangalore, India-based API maker, both linked to testing shortfalls. The letter comes in ...
The US Food and Drug Administration sent warning letters to Target, Walmart, Kroger and Albertsons after some of the stores failed to remove recalled baby formula linked to a large infant botulism ...
The US Food and Drug Administration on Tuesday released approximately 100 warning letters it had sent to drug companies on September 9, alleging that the companies made false or misleading claims on ...
The Food and Drug Administration has sent out warning letters to multiple retailers after stores failed to remove recalled baby formula linked to an outbreak of infant botulism from the shelves.
In September, FDA issued warning letters at three Philips manufacturing facilities across the U.S. and Europe, noting shortcomings in quality control. Impacted facilities include two ultrasound ...
The U.S. FDA has issued a warning letter to Hims & Hers Health (NYSE:HIMS) over its marketing of compounded semaglutide, the weight loss drug marketed under the brand name Wegovy by Novo Nordisk (NVO) ...
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