GUIDANCE DOCUMENT
Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry July 2018
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2018-D-1895
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter 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)).
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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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All written comments should be identified with this document's docket number: FDA-2018-D-1895.