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# Pediatric Information Labeling Guidance
- URL: https://www.fdaweb.com/pediatric-information-labeling-guidance/
- Published: 2019-03-27T12:00:00.000Z
- Updated: 2026-09-15T01:16:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143711

FDA has issued a guidance, *Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling*, to help applicants determine the appropriate placement and content of pediatric information in human prescription drug and biological product labeling. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM341394.pdf?ref=fdaweb.com) says its goal is to provide recommendations to help ensure that information on prescription drug use in pediatric populations—whether positive, negative, or inconclusive—is consistently placed in the proper sections and subsections within labeling so that the information is clear and accessible to healthcare providers.