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 ...

Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like irregular heart rhythm or sleep apnea alerts. They are usually labeled as such.

The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, ...

The design combines multiple textual and graphic ... FDA-approved patient information be reprinted in or accompany drug product labeling. The purpose of this change is to increase the prominence ...

The FDA’s Oncologic Drugs Advisory Committee recently voted to narrow the label for checkpoint inhibitors Keytruda and Opdivo ...

“In accordance with this direction, FDA is delaying the effective date of the final rule ‘Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”’ (89 FR 106064), until ...

Having a tough time reading those food labels? And what constitutes healthy, and can you believe what manufacturers say on a package? The U.S. Food and Drug Administration is trying to help.

The FDA has announced new labeling changes for all testosterone products following a review of clinical trial data, including a TRAVERSE study and postmarket ambulatory blood pressure studies.