Issue Date: March 28, 2019
Issued by: Center for Biologics Evaluation and Research
Topic(s): Labeling, Pediatric Product Development
Status: Final
Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice
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.
Download the Guidance Document
