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

Issue Date: July 15, 2022
Issued by: Center for Biologics Evaluation and Research
Topic(s): Labeling
Status: Final

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 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).

Download the Guidance Document

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