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The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.
FDA published guidance on March 27, 2019 detailing how to determine the placement and content of pediatric information in drug and biologic product labeling. The recommendations help sponsors ensure that information for pediatric drugs is placed in the proper sections and subsections within labeling, so the information is clear and accessible to healthcare providers.
Specifically, the guidance document addresses information regarding drugs that may be ineffective or unsafe in a specific age group and details different scenarios for the type of information being conveyed. The document also discusses information on inactive ingredients and information from nonclinical toxicity studies in juvenile animals.