Docket Number:
FDA-2013-D-0169
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This guidance is intended to assist applicants in determining the appropriate placement and content of pediatric information in human prescription drug and biological product labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products.

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All written comments should be identified with this document's docket number: FDA-2013-D-0169.