The new European Union regulations for medical devices (EU MDRs) will have major implications for the labeling operations of every medical device manufacturer that trades in the EU. The regulations ...
Our cells are constantly communicating, and scientists have developed an efficient way to find out what messages they are sending in protein-packed biological suitcases called exosomes. These ...
One of the FDA’s recent biosimilar guidance documents has drawn criticism for eliminating labeling information necessary for physicians to make prescribing decisions. The guidance document, titled, ...
The FDA approved label for the first U.S. biosimilar, Sandoz’s Zarxio, has raised concerns. Zarxio was launched on September 3, 2015 with a label that does not state that the product was approved as a ...
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