The Pediatric Advisory Committee (PAC) advises and makes recommendations to the FDA about matters involving pediatrics. One of the PAC’s responsibilities is to review, evaluate, and make recommendations on adverse event reports of post market pediatric safety data for certain medical products. The safety reviews enable the FDA to identify safety concerns in children that may not be possible to detect before the product is marketed. The PAC also advises on aspects of Humanitarian Device Exemptions (HDEs) for certain HDE devices that are approved in pediatric patients.
The spreadsheet below includes medical products that have been shared with the PAC as required by federal law, FDA’s safety review information and the PAC’s recommendations.
See the Best Pharmaceuticals for Children Act, Pediatric Research Equity Act and Pediatric Medical Device Safety and Improvement Act for more information.
- Pediatric Advisory Recommendations (XLSX, 70KB)