In the Guidance, the FDA posits that poor pharmaceutical label design can contribute to medication errors. To reduce such errors, the FDA seemingly takes a "pro-trade dress" stance by warning ...

The draft guidance – which is open for comment until 7th April – proposes a risk-based assessment framework that drug developers ...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 ...

The FDA is delaying implementation of a rule that would require food companies to print nutritional information on the front labels of their products. The ...

The FDA guidance specifies that developers show that ... How aggressive FDA will be, or whether states can intervene is unclear.” The labeling issue remains contentious. The guidelines propose ...

The deadline for comments on the proposed rule has been extended to July 15. The U.S. Food and Drug Administration (FDA) is ...

There is, however, some leeway when it comes to sharing scientific information about off-label usage. A recently finalized guidance document (PDF) from the FDA offers recommendations for firms ...