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 ...

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...

FDA to release new guidance soon, clarifying its regulatory framework related to vaccines, particularly COVID-19 shots. Read ...

A top agency official is meeting with industry and FDA staff as he works on guidance clarifying the FDA’s expectations for ...

The FDA announced Monday that it has published draft guidance for manufacturers of pulse oximeters that offers recommendations for the clinical testing and labeling of these electronic medical ...

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

The draft guidance – which is open for comment until 7th April – proposes a risk-based assessment framework that drug developers ...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 currently specifies 30 nutrients that must be included in infant formulas. There are minimum amounts for all 30 nutrients and maximum amounts for 10 nutrients, according to the agency. Among ...

Global public health and safety organization NSF has issued key findings from a survey on the effectiveness of U.S. food ...