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# Indications, Usage Content Guidance
- URL: https://www.fdaweb.com/indications-usage-content-guidance/
- Published: 2018-07-09T12:00:00.000Z
- Updated: 2026-09-15T00:17:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141812

FDA has published a draft guidance, *Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products—Content and Format*, to assist applicants in drafting the Indications and Usage section of labeling for human prescription drug and biological products. The document’s [recommendations](https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm612706.htm?utm%5Fcampaign=07062018%5FFIB%5FFDA%20encourages%20more%20informative%20labeling%20on%20drug%20indications%20and%20usage&utm%5Fmedium=email&utm%5Fsource=Eloqua) include general principles to consider when drafting the Indications and Usage section; what information to include in the section, when to include additional descriptors or qualifiers as part of the indication in the Indications and Usage section; when to include limitations of use in the Indications and Usage section; and how to write, organize, and format the information within the Indications and Usage section.