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 ...

Purpose: The revised prescription drug labeling developed by the Food and Drug Administration (FDA) is described. Summary: A new FDA final rule, "Requirements on Content and Format of Labeling for ...

The FDA has published its long-awaited update to guidance to make sure clinical trials more closely reflect the range of patients that might be treated with a new therapy in the real world.

You may have heard about — or maybe even experienced — the short-term side effects of Ozempic® — such as nausea, vomiting, ...

Wearable AF monitoring devices are extensively used in routine practice worldwide. The FDA has agreed on the use of AF monitoring devices in clinical trials for budiodarone approval. The FDA has ...

Vantis Vascular announced today that it received FDA 510(k) clearance for its CrossFast integrated microcatheter guide extension system. San Jose, California-based Vantis develops the CrossFast ...

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the ...

Inspired by the legacy of Robert Bedoukian, the meeting's theme, "Benevolence," reinforced the industry's commitment to ...

The expanded indication in Ph+ CML-CP increases the population eligible for Scemblix by approximately four times, including newly diagnosed and previously treated adults. Newly diagnosed patients will ...

Bimbo Bakeries USA has drawn a line in the allergen-labeling sand, according to news reports. In response to a June 2024 Food & Drug Administration (FDA) warning letter that scolded the company for ...