Instructions for Use-Patient Labeling for Human Prescription Drug and Biological Products-Content and Format; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Instructions for Use--Patient Labeling for Human Prescription Drug and Biological Products--Content and Format." This guidance provides recommendations for developing the content and format of an 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). The IFU is written for patients (or their caregivers) who use drug products that have complicated or detailed patient-use instructions. The recommendations in this guidance are intended to help ensure that patients receive clear and concise information that is easily understood for the safe and effective use of such products. This guidance finalizes the draft guidance issued on July 2, 2019, entitled "Instructions for Use-- Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products--Content and Format."