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GUIDANCE DOCUMENT

Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format July 2022

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2019-D-1615
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

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). 

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All written comments should be identified with this document's docket number: FDA-2019-D-1615.

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