Learn why the FDA is asking to update testosterone replacement therapy labels after a major review of new evidence.

A “black box” warning on a health product sounds pretty scary – maybe even more so when it’s suddenly being taken off the packaging. Americans were reminded of this type of public health messaging on ...

Why is the HHS asking for revisions? The Food and Drug ​Administration as of 2015 required testosterone therapy labels 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 ...

Anyone who has picked up a box of alli from a drugstore shelf without a prescription now faces a new risk disclosure. The FDA ...

Share on Pinterest The FDA has initiated changes to the black box warnings on HRT products. Lupe Rodriguez/Stocksy The Food and Drug Administration (FDA) has approved drug labeling changes to black ...

Federal health officials are warning consumers that the weight loss pills alli and Xenical may cause severe liver damage in rare cases. The Food and Drug Administration said Wednesday it has added a ...

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 ...

Although the United States requires a warning label on alcoholic beverages, alcohol-related deaths have risen steadily over the past two decades. However, new labels warning of specific disease risks, ...