
FDA Gives Guidance on Pediatric Information in Labeling
The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.
FDA published
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.
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