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
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