The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, ...

The FDA announced Monday that it has published draft guidance for manufacturers of pulse oximeters that offers recommendations for the clinical testing and labeling of these electronic medical ...

A label begins with highlights, a succinct, half-page summary of the information that health care practitioners most commonly refer to and view as most important (Figure 2). [4] This section ...

Products must note that they can increase blood pressure, but boxed warnings about adverse cardiovascular events can be ...

Exelixis (EXEL) wins FDA approval for Cabometyx for advanced pancreatic and extra pancreatic neuroendocrine tumors in ...

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The FDA approved an expanded label for Iluvien, which is now indicated for the treatment of chronic noninfectious uveitis ...

The draft guidance – which is open for comment until 7th April – proposes a risk-based assessment framework that drug developers ... such as user interface and labelling, data management ...

Based on the TRAVERSE trial results, the FDA has recommended that the Boxed ... "We are excited about these label changes, including the removal of the Boxed Warning, as we expect the changes ...

Additionally, the label now reflects data from a lactation study following the 2019 FDA guidance on Clinical Lactation Studies. The study, which involved 15 healthy lactating women, assessed the ...