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.” ...

Under the previous FDA rule, which is being updated for the first time in 30 years, foods like salmon couldn't be labeled ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation ...

The FDA announced Monday that it has published draft guidance for manufacturers of pulse oximeters that offers recommendations for the clinical testing and labeling of these electronic medical ...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 top agency official is meeting with industry and FDA staff as he works on guidance clarifying the FDA’s expectations for ...

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 ...

The draft guidance – which is open for comment until 7th April – proposes a risk-based assessment framework that drug developers ...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

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