The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for violations of current good manufacturing practices (CGMP). Additionally, ...
Our FDA/Food, Drug & Device Team analyzes the practical considerations for adhering to the Food and Drug Administration’s final rule for laboratory-developed tests (LDTs). The five stages of the ...
In a major advancement for decentralized health care and environmental monitoring, researchers at Kumamoto University have ...
Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...
US Food and Drug Administration (FDA) Commissioner Margaret Hamburg recently announced that her agency would soon end a long-standing policy of enforcement discretion toward a classification of ...
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