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 ...

The FDA has proposed placing strong warning labels on many over-the-counter painkillers, cautioning patients about the risks of possible liver failure from taking them too often. More than 200 million ...

The US Food and Drug Administration (FDA) has clarified definitions and appropriate reporting of minor label changes for over-the-counter (OTC) drugs in draft guidance expected to reduce regulatory ...

In an essay published in this week’s issue of the New England Journal of Medicine, a trio of medical researchers team up to propose a novel way to trim some of the nation’s ballooning health care ...

The Food and Drug Administration has announced that the labels for two eczema drugs -- Elidel cream and Protopic ointment -- will now include warnings about a possible risk of cancer, as well as a ...

Obesity can alter the action of many types of medications in ways affecting safety and/or efficacy, but this often isn’t mentioned in the labels. Experts in obesity and pharmacology are trying to ...

The FDA has added new warnings to GLP-1 medications such as Ozempic, Wegovy, and Mounjaro about pulmonary aspiration risk ...