The Orphan Drug Act of 1983 was enacted to provide financial incentives to stimulate drug development for rare diseases. In recent years, concerns have been raised regarding these orphan drugs, ...

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 ...

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 ...

Meals and snacks with “GLP-1 Friendly” labels on the packaging are becoming more common in U.S. supermarkets as a growing number of Americans try obesity drugs like Wegovy and Zepbound to lose weight.

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 ...

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 provides ...