Regulated by authorities such as the FDA as ‘Software as a Medical ... regulatory ambiguity and clinical validation. First, it clarifies how end-user outputs from PDTs are categorized as either ...

Readers had a lot to say about my latest column on the Food and Drug Administration’s proposed front-of-package labels. Most ...

All things considered, it’s at least as likely to make health outcomes worse as it is to make most people healthier.

Initially approved in 2019 for use alongside oral antidepressants, this label expansion follows a priority review from the FDA. The approval was based on data from the Phase IV TRD4005 study ...

The proposed nutrition label provides information on saturated fat, sodium and added sugars content in a simple format.

This year, the Food and Drug Administration (FDA) is overhauling food labels, with a major focus on redefining what qualifies ...

The US Food and Drug Administration (FDA) is urging manufacturers to revise labeling of transmucosal buprenorphine products to ease access to higher doses needed due to the rise of high-potency ...

The U.S. Food and Drug Administration (FDA) is taking a stronger approach toward supporting health goals in 2025 and beyond by setting the tone ...

On January 16, 2025, the U.S. Food and Drug Administration (“FDA”) published a highly anticipated proposed rule on front-of-package (“FOP”) ...

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 also has several different designs in mind for the proposed new label depending on factors such as the type of product and size of the package, as seen below. The Nutrition Info box would ...

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