Labeling for CBER-Regulated Products

The Federal Food, Drug, and Cosmetic Act authorizes FDA to require that prescription drug labeling provides healthcare professionals and patients with adequate information to permit safe and effective use of drug products. The Public Health Service Act provides legal...

Drug Trials Snapshots: IOMERVU

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar...