Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products

Update on New Guideline; by USFDA Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry This 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). U.S. Department of Health and Human Services Food and Drug Administration Office of Combination Products (OCP) Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) July 2022 Labeling