Pediatric Labeling Changes
The FDA is transitioning to a new and improved database to track pediatric labeling changes and completed pediatric clinical trials. The spreadsheet below shares this information in the interim. Information gaps may occur in the spreadsheet while we work to transition to the new database.
The pediatric labeling changes 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 on product labels 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.
Each pediatric labeling change listed in the spreadsheet includes the specific drug or biological product, date of the pediatric labeling change, indication(s) studied, type of submission and therapeutic category.
Pediatric study characteristics for the clinical trials conducted to support each pediatric labeling change also are provided, including the type of study, study design, number of pediatric participants, ages studied and demographic information for BPCA clinical trials, if available.
The spreadsheet also provides a summary of the labeling change. The data in the spreadsheet are current as of June 30, 2021 and updated on a quarterly basis.