Final Guidance: Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling

The U.S. Food and Drug Administration (FDA) is making available a final guidance titled Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling. This guidance is intended to assist applicants in determining the appropriate placement and content of pediatric information in prescription drug labeling.  This guidance will help ensure that pediatric information is consistently placed in the proper parts of labeling so that the information is clear and accessible to healthcare providers.  The guidance provides several examples of pediatric use statements in the Pediatric Use subsection of labeling for (1) drugs with a pediatric indication, (2) when the available evidence does not support a pediatric indication, (3) when there is no evidence to support a pediatric indication because the studies have not been conducted or are ongoing, and (4) when a drug is contraindicated in pediatric patients. More information on FDA’s efforts pertaining to labeling and pediatric drug development is available at FDA’s PLR Requirements for Prescribing Information and Pediatrics page.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM341394.pdf?utm_campaign=SBIA%3A%20Pediatric%20Information%20Incorporated%20Into%20Human%20Prescriptio&utm_medium=email&utm_source=Eloqua&elqTrackId=A7FDB580474DF2DED53BDFBA32391D3C&elq=6b990aefce424ff4a2dc7a555b49049e&elqaid=7369&elqat=1&elqCampaignId=6032