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GUIDANCE DOCUMENT

Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry July 2018

Draft

Not for implementation. Contains non-binding recommendations.

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

Docket Number:
2018-14535
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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)).
 


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2018-14535.