A national survey of 600 U.S. adults examined how Americans read and follow prescription and over-the-counter drug labels. The results reveal widespread gaps in understanding that may contribute to ...

Federal law requires every prescription drug to include a document describing dosing guidelines, contraindications, results from clinical trials and safety considerations. But a spate of recent court ...

Courts have relied on the differences in the regulations of the Food and Drug Administration (FDA) governing the labeling of brand-name and generic prescription drugs to justify the differences in the ...

Federal drug regulators concluded that three obesity medicines should no longer carry label language warning about suicidal thoughts or behavior. The decision covered Wegovy, Zepbound and Saxenda ...

The US Food and Drug Administration (FDA) on Friday released draft guidance describing the process for drug companies when they have to update a generic’s label after the reference product (for which ...

Labels for popular weight-loss drugs no longer need to warn that they may increase the risk of suicide, federal regulators said in a Jan. 13 update. The Food and Drug Administration said that it ...

Regulatory Focus' ongoing series of Regulatory Explainers take complicated regulatory topics and make them simple enough for anyone to understand. In our latest Regulatory Explainer, we ...

This article originally appeared on ProPublica. Landmark legislation designed to alert consumers to where their drugs were made is headed for a full Senate vote, but safety experts say the ...

Drug warning labels must comply with federal regulations and receive approval from the Food and Drug Administration (“FDA”) before going to market. Therefore ...

Montelukast, sold for decades under the brand name Singulair and taken by millions of people for asthma and seasonal allergies, carries one of the most serious safety labels the Food and Drug ...