Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry

Issue Date: July 6, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Labeling
Status: Draft

Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry

This guidance is intended to assist applicants in drafting the INDICATIONS AND USAGE section of labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products2 (21 CFR 201.57(c)(2)).

Download the Guidance Document

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