Reports, Statistics, Reviews and Databases

The FDA tracks information relevant to its efforts to assure that pediatric patients have access to safe and effective medical products. For example, the FDA is required to track and make publicly available certain pediatric information resulting from pediatric clinical trials conducted pursuant to the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003. 

Pediatric Labeling Changes

Find pediatric labeling changes and study characteristics data highlighting key pediatric information obtained from studies submitted to the FDA in response to legislative initiatives, including BPCA and PREA. 

Reports to Congress

Find the FDA’s reports to Congress about topics relevant to pediatrics, including status updates on implementation of BPCA and PREA.

Pediatric Study Statistics and Reviews

Find statistics pertaining to pediatric study progress, waivers, and deferrals, Written Requests and Pediatric Exclusivity, and access FDA’s reviews of pediatric studies conducted in response to BPCA and PREA.

Pediatric Advisory Committee (PAC) Recommendations and Updates

Find recommendations from the PAC about adverse event reports of postmarket pediatric safety data for certain medical products.

FDA Track

Find statistics for the FDA’s Office of Pediatric Therapeutics’ efforts in outreach, safety measures, and international collaboration.