This guidance provides recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drug and biological products and drug-device or biologic-device combination products submitted under a new drug application (NDA) or a biologics license application (BLA). , The IFU is developed by applicants for patients who use drug products that have complicated or detailed patient-use instructions. The recommendations in this guidance are intended to help develop consistent content and format across IFUs and to help ensure that patients receive clear, concise information that is easily understood for the safe and effective use of such prescription products. Thus, the recommendations in this guidance are ultimately intended to enhance patients’ understanding of IFUs and facilitate the development and approval of IFUs that are clear and helpful to patients.