The FDA said the problems “raise concerns about the quality and integrity of data generated by the labs,” which provide third-party testing and validation data services for device firms.
U.S. health inspectors are still struggling to address a massive backlog of pharmaceutical plants that went uninspected ...
Douyin, the Chinese version of TikTok, spurred a creator economy with more than 700 million active users. The social media ...
The US Food and Drug Administration (FDA) has sent warning letters to two Chinese nonclinical testing laboratories regarding laboratory oversight failures and animal care violations. The ...
"Knockoffs are a plague on small businesses, that costs them time, money and may put them out of business," Cuban wrote in an ...
The legislation is intended to prevent US pharmaceutical companies that receive federal funding from working with five Chinese services ... biotechnology innovation, drug development, and patient ...
The Biden administration has cracked down on Chinese e-commerce platforms by trying to close a trade loophole.
The Food and Drug Administration expanded the approval of Kisqali, a drug for metastatic breast cancer, to also treat ...
Under the FDA's own guidelines, factories that haven't been inspected in five or more years are considered a significant risk ...
The Biden administration added China to its illicit drug watchlist on Monday, despite previously touting cooperation with ...
An investigator has backed the World Anti-Doping Agency's handling of a case involving 23 Chinese swimmers who failed drug ...
The Food and Drug Administration sent warning letters to two Chinese nonclinical labs that provide testing and validation data services to device manufacturers. The letters, which the FDA sent to ...