Expert Insights

Expert Insights

Pediatric Labeling Database Updates

Pediatric Labeling Database Updates
06 March 2019

When adults are advised by their health care professional to use a medication, they can expect to receive information, backed up by data from clinical studies, on the correct and safe dose to take. For drugs used in children, this information, historically, may not have been available, since not all products were studied in children and adult products may have been used off-label in pediatric populations. With the entrance of new regulatory requirements of ICH E11 (R1) “Clinical Investigation of Medicinal Products in the Pediatric Population” in February 2018, the FDA and drug developers are aiming to further improve pediatric research and information globally.

The FDA created the Pediatric Labeling Information Database to make it easier for parents and health care professionals to find information on pediatric medications. It periodically updates pediatric labeling information on this database and now has this information converted to a sortable, searchable table, located here: New Pediatric Labeling Information Database.

This list highlights key pediatric information from studies submitted in response to pediatric legislative initiatives. The new format lists the labeling date, trade name of the product as well as generic name or proper name, the therapeutic category, indications studied, and a summary of the label changes made. CBER regulated products have an asterisk (*) by the proper name.

The FDA also provides a safety reporting page with information on products that have been tied to safety problems specifically related to children. This page lists products that have been the subject of an adverse event report presented to the FDA’s Pediatric Advisory Committee (PAC), identifying any undesirable experience associated with a medical product. The committee’s recommendation is given if further actions were necessary to ensure safe use of the product in children. The table is searchable by keyword, including drug name, PAC date, or recommendation(s).

Synteract is ready to help you with questions you may have concerning regulations and planning for your pediatric clinical trials. Contact us to see how we can help you.

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