Instructions for Use Patient Labeling for Human Prescription Drug and Biological Products Content and Format

Instructions for Use Patient Labeling for Human Prescription Drug and Biological Products Content and Format guidance provides recommendations for developing the content and format of a patient Instructions for Use (IFU) document for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA).