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Pediatric Labeling Changes

The pediatric labeling changes and study characteristics data highlight key pediatric information obtained from studies submitted to the FDA in response to legislative initiatives, including the Pediatric Research Equity Act (PREA) of 2003, the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Rule of 1998. These laws encourage and, in certain circumstances, require pharmaceutical companies to develop medicines for children. Having information in product labeling about a medicine’s safety, effectiveness and dosing for children is important to ensure health care professionals can make evidence-based decisions about treating children. The legislation has led to a dramatic increase in pediatric studies submitted to the FDA and resulted in new pediatric information in labeling.

Pediatric Labeling Changes Spreadsheet

This spreadsheet contains all pediatric labeling changes made pursuant to the pediatric legislative initiatives. Each pediatric labeling change includes the date of the pediatric labeling change, specific drug or biological product, indication(s) studied, a summary of the labeling change, therapeutic category and type of legislation.

Pediatric Labeling Changes Spreadsheet (XLSX-258KB)

Pediatric Study Characteristics Spreadsheet

This spreadsheet contains pediatric study characteristics for the clinical trials conducted to support each pediatric labeling change, including the study number, type of study, study design, number of pediatric participants, ages studied, number of study centers, number of countries and, for BPCA clinical trials, any available racial and ethnic information. The data in the spreadsheet includes pediatric studies that resulted in labeling changes made on September 27, 2007 and thereafter pursuant to the FDA Amendments Act (FDAAA).  

Pediatric Study Characteristics Spreadsheet (XSLT-287KB)

The pediatric labeling changes spreadsheet contains labeling changes through December 2021.  The pediatric labeling changes and studies spreadsheet contains data through September 2021.  These spreadsheets are updated quarterly.


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